Для содержимого этой страницы требуется более новая версия Adobe Flash Player.

Получить проигрыватель Adobe Flash Player





News and Events:

Standard operating procedures (SOPs)

 

Here you will find answers to the following questions:

  • What is the relevance of operating procedures for GMP?
  • Which factors must be taken into consideration with regard to the organisation, structure, numbering and identification of an operating procedure?
  • How are the contents of operating procedures checked and, if necessary, changed or updated?
  • Which workflows have qualified for invalidation or for operating procedure archiving?
  • Example: SOP "Compilation and administration of SOPs"

Operating procedures should be the basis of specifications for actions and decisions. They should help both managers and members of staff to work and to take decisions in a professionally correct manner.

The term"operating procedure" has a variety of synonyms: operational procedure (EU GMP Guideline), written procedure (21 CFR 211), standard operating procedure (SOP), standard procedure instruction, procedure instruction, manufacturing instructions, test instructions, test procedure, operational instructions, etc.

The aim of operating procedures is to ensure that quality-related work and workflows

  • are correctly carried out
  • immediately
  • by everyone

This also confirms that the addressees of operating procedures are the staff of the company. It is only a secondary purpose of operating procedures to make workflows comprehensible for external parties (e.g. customers, members of authorities).

The term "operating procedure" (standard operating procedure - SOP) is used in this chapter with the following definition:

An operating procedure is an approved, written specification which regulates a specific procedure that is repeated on a regular basis. It regulates individual processes and is relevant to sections of an organisational structure.

Each operating procedure is a set of documents which provides information and instructions of an organisational, administrative and technical nature for the implementation of working processes. Whether or not these instructions contain specific requirements, such as for products, manufacturing processes or cleaning procedures, depends on the nature of the company documentation system. The important factor is to ensure that the contents are clearly assigned to the various documents.

Operating procedures must be adapted to changes in requirements and procedures. In the history of an operating procedure, typical stages are passed through (see figure 15.D-1) which characterise the current situation of the document (see chapter 15.A.3 Formal requirements).

Link to 15.D-1.jpg
to enlarge, click here!

Figure 15.D-1
History of an operating procedure

The operating procedure must be dealt with in accordance with fixed guidelines at each of these stages in order to guarantee that the document is suitable for its intended purpose. It is more advisable to describe these requirements in a separate operating procedure ("ex SOP"), which sets out the general procedures for each stage of the history. (see chapter 15.D.10 Example of an SOP "Compilation and administration of operating procedures")

15.D.1 Compilation

The life cycle of an operating procedure begins with its compilation. Operating procedures can be initiated by both the employees on site and by quality assurance, in particular for quality-related contents.

New operating procedures should be compiled by an employee who has practical experience of the operating procedure regulations and is familiar with the workflows described therein. This is the only way to create an "authentic" document which can actually be used in practice. Technical competence is an important precondition for ensuring that the operating procedure can actually be used as "instructions for working".

The responsibility for compiling an operating procedure lies with the head of the department to which the operating procedure essentially relates. He can delegate the task of compiling the procedure to a qualified member of staff (see above).If an operating procedure is enforced over several areas, its contents must be harmonised.

The larger the area to which the operating procedure relates, the greater are the requirements for harmonisation of the text of the operating procedure with what happens in practice. In this case, the compiler is obliged to reconcile all the different requirements during harmonisation meetings. This can mean that, before an operating procedure is compiled, the workflows which it concerns must be revised or, if necessary, harmonised, to enable them to be represented in written form.

In accordance with §19 of the German Drug Law, members of staff with pharmaceutical responsibilities (head of production, head of quality control, qualified person) in particular should be considered for the harmonisation of such contents.

Commenting procedure: For SOPs which are valid over larger areas, it has proved useful to compile a draft operating procedure in the first instance and to then have the draft circulated to future users. For this procedure, more time is devoted to the conceptional phase of compiling an operating procedure. The subsequent approval procedure then becomes a "formality".

A style of language which is easy to understand should be selected for compiling an operating procedure, so that the contents can be understood by the addressees (recipients). The language used in the document is the medium through which the compiler (sender) of the operating procedure communicates with those to whom the procedure is addressed. Use of the correct style of language can be a decisive factor in determining if and how the contents of the operating procedures are received by the staff. Operating procedures should be compiled in a brief, concise and understandable style.

The language shall be one of the "official" languages used in the company (in multinational companies, this tends increasingly to be English). It is more important, however, that the language in the operating procedure is understood by the relevant addressees.Both language and style must therefore be adapted to the scope of application. The following applies in principle: The more precise and "operative" the subject to be described, the more detailed, accurate and clear the specifications in an operating procedure must be. These differences in detail become clear when comparing an operating procedure, for example, which sets out the company's strategical considerations for validation, with an operating procedure for cleaning a blender.

The compilation is documented with the appropriate signature together with the name and role of the compiler as well as the date of signing the operating procedure.

15.D.1.1 Design and format

Operating procedures should be uniform in design and format (see chapter 15.A.3 Formal requirements).

A properly structured design enables a rapid overview and makes it quicker to pinpoint areas of the text. A uniform design facilitates the integration of changes and reduces the time needed for working with the operating procedure. This not only considerably facilitates the work of the staff who deal with operating procedures on a daily basis , it also enables outsiders, who do not have to deal with actual operating procedures so frequently, to orientate themselves more easily. figure 15.D-2 shows a suggested structure for an operating procedure.

Figure 15.D-2 Suggested structure of an operating procedure

Suggested structure of an operating procedure

  • Identification data (cover sheet)
  • Index of changes
  • Contents
  • Introduction
    • Background/objectives
    • Other relevant rules
    • Validity
    • Definitions/abbreviations:
  • Implementation
  • Facilities
  • Distribution list

A uniform format makes the procedure easier to read, increases its recognition factor, increases familiarity and thus also the acceptance of an operating procedure. Format issues such as font type and size, line spacing, paragraph formatting, layout of document headers and footers, borders or titles, can be uniformly set using document templates.

The identification data on the cover sheet characterises an operating procedure with regard to its technical data, e.g. title, number or number of pages of the operating procedure.

The index of changes offers the user of the operating procedure fast information on the contents that were changed in comparison with the previous version.

The table of contents is particularly useful for improved orientation within a more extensive operating procedure. The introduction will point the reader to the contents of the operating procedure. The reason for the operating procedure is explained in the section on background/objectives, where relevant regulatory requirements, for example, are specified. Operating procedures with related content should be specified in relation to other regulations very carefully. On the one hand, understanding of the context is increased by specifying further literary sources; on the other hand, more maintenance is required in the event of modifications. The validity already defined on the cover sheet is further substantiated in the scope of validity section, e.g. by naming the manufacturing facility responsible for the contents. The chapter entitled Definitions/abbreviations has proved particularly useful for operating procedures which introduce new concepts and procedures into the working day. New terms are defined here and given abbreviations, if appropriate. These abbreviations can then be used in the text. Abbreviations which are not explained in the chapter entitled Definitions, Abbreviations should only be used in the operating procedure if they are universally comprehensible. Alternatively, a glossary can be introduced in the company, in which concepts are uniformly defined and synonyms given.

Time to get serious.The contents of the operating procedure already indicated in the title are described through the course of the document. The procedures to be regulated, including the associated responsibilities and competencies, are set out to this end.It is often beneficial to illustrate procedures visually using graphics, such as flow charts, for example. When describing the procedures, a chronological sequence must be ensured and formulations must be brief and precise. This is the only way to ensure that the operating procedure can help the user to carry out their work according to recipe.

The sections to which the operating procedure must be distributed are listed in the distribution list.The distribution list is composed of "compulsory" and "for information" recipients.

In addition to the contents structure described above, an operating procedure can also be subdivided into the following elements with regard to layout.

  • Cover sheet
  • Successive pages
  • Appendices (if required)

It has proven useful to summarise the identification data of an operating procedure in a cover sheet.

The cover sheet contains the following information:

  • Company description / logo
  • Description of the document - here: Operating procedure
    (the same layout can be used for the qualification documentation, for example).
  • Title of operating procedure
  • Number of the operating procedure
  • Date of validation:
  • Page number, number of pages
  • Number of appendices
  • Details of which operating procedure(s) are replaced by this one.
  • Compulsory for
  • For information
  • Signatures of the checker and the approver (several people can function as compilers, checkers or approvers if and when required)
  • The validity of an operating procedure is specified in the "compulsory for" field. This sets out the distribution list for the operating procedure together with the "For Information only" field.

The successive pages are numbered serially and contain certain identification data such as title, number and validation date, for example.

If required, the text of the operating procedure can also be added to with appendices. These can be checklists or forms, for example, which facilitate the processing of a procedure. Appendices can be included in the serial page numbering. However, numbering appendices separately will make it easier to exchange them. With interchangeable appendices, each page has its own numbering and also a version number with date. These appendices can then be updated if required and exchanged if they are still consistent with the contents of the operating procedure.

15.D.1.2 Identification

Operating procedures should be identified in accordance with a uniform identification system. This facilitates the administration of the operating procedure. In practice, an alphanumerical code has proved useful for devising such a system.

The following information can be integrated into the alpha-numerical codes("number").

  • Compiling unit
  • Validity
  • Subject area
  • Serial number
  • Version

Each number may be assigned once only in order to guarantee that a number is clearly assigned to an operating procedure. The number of an operating procedure no longer in force must not be reassigned in the future.

Identification systems should not be too "descriptive", e.g. the validity should not be selected in too much detail in order to keep the necessary maintenance to a minimum.

The assignment of an operating procedure to its associated subject area is carried out by the compiler.

Example: the operating procedure "Compilation and administration of operating procedures" - No. QA-AD-001-01 - was newly compiled by the quality assurance unit (QA) from the "Administration" subject area (AD) with serial number 1 (001) (version 1 (01)).

15.D.2 Approval and implementation

The approval cycle, which comprises the "checking" and "approval" phases (see chapter 15.D.10 Example of an SOP "Compilation and administration of operating procedures"), guarantees that the operating procedure is suitable for use at a later stage.

  • The operating procedure must be correct, that is, the contents must match the objective facts.
  • The operating procedure must be up to date, that is, the contents must match the facts as they currently exist.
  • The operating procedure must be focused, that is, the contents must reproduce the objective facts in a suitable way.

The operating procedure is valid starting from the validation date and must be followed by the group of people specified in the distribution list. The validation date must be chosen such that the operating procedure can be distributed and taught in good time in accordance with the approval cycle. There must be sufficient time before the validation to guarantee that the operating procedure can be used throughout the area in which it is valid on the day that it is implemented.

Staff whose roles are specified in the "exSOP" are responsible for approval and implementation. The operating procedure is typically approved by the respective head of area or department and implemented by a specific employee in the quality assurance department.

15.D.3 Training

To enable an operating procedure to be implemented, the employees concerned must know and understand the contents and be able to use them. To this end, training on the operating procedure is provided.

Depending on the contents, operating procedures can be taught as both independent study (simply by reading up) and also as part of a detailed training event. It is therefore beneficial to give joint training on operating procedures with similar contents. This not only reduces the time required, but also promotes understanding because analogies and also differences in the operating procedures can be worked through.

In any event, the training must be documented.

Operating procedures should be components of continued training which ensues from the initial training. "Key SOPs", such as those for sanitising or for handling deviations, for example, should be the subject of regular training sessions.

Training should be provided by people who, on one hand, are familiar with the contents of the procedure and who, on the other hand, have the necessary didactic knowledge to convey the contents of the specifications to those present in a lasting manner.

As part of the training procedure, it is important to provide an insight into the necessity of the quality of medicinal products and into the advantages of clear task descriptions and clearly written responsibilities and competencies.

15.D.4 Usage

Assuming that the operating procedure is available on site, the actual "vital" section in the life cycle of an operating procedure now begins: its application.

This is when the contents of the operating procedure are applied. In an ideal situation, the operating procedure itself remains in the background and is only used to either answer specific individual questions on a certain procedure or as a basis for the training. The preconditions for this ideal situation are qualified, motivated staff and successfully implemented training measures.

Preconditions for the application of operating procedures in accordance with GMP are listed in figure 15.D-3.

Figure 15.D-3 Preconditions for the application of operating procedures in accordance with GMP.

Preconditions for the application of operating procedures in accordance with GMP

Degree of implementation:the member of staff

Precondition:the member of staff

... knows the operating procedure

... has been informed of the new or changed operating procedure

... knows what is in the operating procedure

... has obtained and read the operating procedure

... has understood the operating procedure

... is qualified or has been trained

... has accepted the operating procedure

... agrees with its contents

... follows the operating procedure

... is motivated and possesses the required resources

15.D.5 Review

Operating procedures must be up to date. They must therefore be adapted to changes in circumstances if necessary. Operating procedures must be checked at regular intervals to ensure that they are up to date (Revision).

Operating procedures must be changed immediately if the contents are modified. Nevertheless, it will still be necessary to carry out a check after a specific time interval has elapsed. The length of this time interval is determined by the company alone, time intervals from two to three years have proven to be the most suitable.

A checking procedure can have the following results:

  • "still up to date":
  • "for review":
  • "for withdrawal"

The results of checking an operating procedure are documented on a corresponding form, the distributees are informed of the result and the form is archived (see chapter 15.D.7 Withdrawing an operating procedure).

15.D.6 Changes

It can be discovered, when checking an operating procedure, that it is necessary to change and update the contents and adapt them to the conditions which have been changed since the procedure was first compiled.

Changes made can be presented in a clear format using an index of changes. The index of changes lists changes which have been made in relation to the previous edition as key points. The index of changes is a separate structured item for an operating procedure.

For more significant changes, it would be better to start a commentary procedure prior to the approval procedure (see chapter 15.D.1 Compilation). The process for making changes to the procedures should then be as described under chapter 15.D.2 Approval and implementation.

In the event of a shortcoming related to quality, the procedure must be blocked immediately and changed as soon as possible.

Independent, hand-written entries in approved operating procedures are not permitted.

15.D.7 Withdrawing an operating procedure

Operating procedures which have become invalid and which will not be replaced by a different operating procedure or consecutive version must be withdrawn in writing.

The operating procedures which have been withdrawn must be removed from circulation in a regulated procedure, in order to prevent them from being used unintentionally.

15.D.8 Administration

The history of an operating procedure is accompanied by various administrative actions. These actions can include the following activities:

  • Compiling/maintaining overview lists in valid operating procedures
  • Numerical assignment
  • Monitoring the approval procedure
  • Identifying/distributing operating procedures
  • Monitoring the checking procedure
  • Archiving

Depending on how the company is organised, operating procedures can be decentrally administered (e.g. throughout the company) or by a central location (e.g. a documentation point/an employee appointed to deal with operating procedures).

15.D.8.1 Status identification

Regardless of whether an operating procedure is a draft, an approved original or a paper copy, the revision status and current status of an operating procedure should be clearly visible to the user.

Identification should also prevent unauthorised production and the distribution of unauthorised copies of operating procedures. This identification can be as creative and time-consuming as desired, but it must be borne in mind that an identification system which is less sophisticated will not be successful if the staff are not motivated and trained. Pre-printed paper (e.g. with a red "original" imprint), stamped wording or perforated pages can be used as identification measures which are sensible in terms of both effort and usefulness.

15.D.8.2 Distribution

The operating procedure must be available for consultation on site throughout its period of validity. It must therefore be distributed to the sections/persons listed in the operating procedure distribution list (see figure 15.D-5). Regardless of whether or not the procedure will be distributed electronically or in paper form, this should be carried out promptly before the validity date is reached. The distribution should be documented and the receipt confirmed (see figure 15.D-6).

15.D.8.3 Integration

It can sometimes be necessary to make current operating procedures from other areas valid in your intended area. The following procedures are available for integrating operating procedures:

  • New version of the operating procedure with corresponding changes to the validity/distribution list.
  • Compiling a "cover sheet version", i.e., the operating procedure is provided with an area-specific cover sheet and enforced via the usual approval procedure.
  • Compiling an operating procedure.

15.D.8.4 Use of computerised systems

Once a certain number of operating procedures and a large number or group of users has been reached, an overview of valid operating procedures and their distribution and also of previous versions can only be achieved with an electronic documentation system.

Program functions of an operating procedures administration system can be:

  • Writing, reading and editing functions
  • Assignment and administration of identification data
  • List of keywords and/or full text research
  • Cross-reference (left) to other operating procedures
  • Distribution of official copies
  • Compilation of write-protected text files (e.g. as pdf files)
  • Search function dialogue boxes for researching operating procedures
  • Receipt
  • Training documentation

The validation of such a system must show that all program functions are working as intended. Important aspects of the validation are, for example, the allocation of identification numbers, the various authentication functions (e.g. reading, amending), the correct functioning of enquiry criteria and data security. The effort required for validation increases in proportion to the extent to which the computerised system not only completes and simplifies the documentation on paper but also totally replaces it.

15.D.9 Archiving

The archiving of the operating procedures guarantees that contents can be reconstructed later on within a specific period of time.

All versions of the original operating procedure and the associated appendices as well as all the checking forms are archived in the administration area, e.g. in Quality Assurance or with the SOP representative.

The receipts are administered together with the distribution list. The index of changes (see figure 15.D-8), which lists the amendments to all previous versions chronologically, is archived at the same time as the withdrawal of the operating procedure from circulation.

The archiving period for operating procedures is in line with the regulatory requirements for the archiving of documents.

15.D.10 Example of an SOP "Compilation and
administration of operating procedures"

An example for an SOP for the "Compilation and Administration of SOPs" is provided on the following pages.

Figure 15.D-4 Sample SOP "Compilation and administration of
operating procedures" 

Company name

Logo

Operating procedure

SOP no. QA-AD-001-01

Title

Compilation and administration of operating procedures

valid from 1 January 2000
Page x of y

 

Appendix 4
Replaces SOP no.

Compulsory for
Production
Quality control
Formulation
Quality Assurance

For information
Central documentation

Dr. Redneb

Quality assurance/
documentation officer

06.12.98

 

created by

Job/role

Date

Signature

Dr. Rehtiep

Quality Assurance/
Head of Documentation

07.12.98

 

checked by

Job/role

Date

Signature

Dr. Saam

Quality Assurance/
Head of Department

08.12.98

 

approved

Job/role

Date

Signature

Index of changes
- new compilation

Contents

1 Introduction

1.1 Background/objectives

1.2 Other relevant rules

1.3 Validity

1.4 Definitions

2 Implementation

2.1 Responsibilities

2.2 Layout, design and structure of an operating procedure

2.2.1 Cover sheet

2.2.2 Index of changes

2.2.3 Table of contents

2.2.4 Introductory section

2.2.5 Implementation section

2.2.6 Appendix

2.2.7 Distribution list

2.2.8 Receipt

2.3 Implementing an operating procedure

2.3.1 Compilation

2.3.2 Checking

2.3.3 Approval

2.3.4 Implementation

2.4 Training for operating procedures

2.5 Administration of operating procedures

2.5.1 Numbering and identification

2.5.2 Distribution

2.5.3 Archiving

2.6 Checking operating procedures

2.7 Changing an operating procedure
2.8 Withdrawing an operating procedure

1 Introduction

1.1 Background/objectives

Important work processes must be set out in accordance with the rules of Good Manufacturing Practice. This must be done in writing. The processes must be described using operating procedures (process descriptions).

This operating procedure describes rules for the compilation and administration of operating procedures in the company.

1.2 Other relevant rules

SOP Change Control

1.3 Validity

This operating procedure is valid for the compilation and administration of operating procedures in the areas of production, quality control, formulation and quality assurance in the company.

1.4 Definitions

Operating procedure (Standard Operating Procedure, SOP)

To describe work processes to be implemented, safety precautions to be taken and other measures which are directly or indirectly relevant to the production of medicinal products.

2 Implementation

2.1 Responsibilities

The responsibility for compiling an operating procedure lies with the manager of the department to which the operating procedure essentially relates.

The manager can transfer the task of compiling the procedure to a qualified member of staff.

2.2 Layout, design and structure of an operating procedure

Operating procedures must be compiled using the relevant "SOP" format template.This sets out the formal requirements for the layout (e.g. headers/footers, font style and size, line spacing).

Operating procedures are composed of a minimum of the following sections:

  • Cover sheet
  • Change index
  • Contents
  • Introductory section
  • Implementation section
  • Appendices
  • Distribution list
  • Receipt

These main sections can be extended if required.

2.2.1 Cover sheet

The cover sheet must contain at least the following information:

  • Company description / logo
  • Designation as an "Operating Procedure"
  • Title of operating procedure
  • Number of operating procedure
  • Date of validation:
  • Page number, number of pages
  • Number of appendices
  • Details of which operating procedure(s) are replaced by the existing SOP.
  • "Compulsory for"
  • "For information"
  • Signature of the compiler, the checker and the approver

2.2.2 Index of changes

The change index lists changes which have been made in relation to the previous edition as key points.

2.2.3 Table of contents

The table of contents is particularly useful for better orientation within a more extensive operating procedure.

2.2.4 Introductory section

The introductory section is structured according to the following points:

  • Background/objectives
  • Other relevant rules
  • Validity
  • Definitions/abbreviations:

Background/objectives: the reason for the operating procedure is explained in the section entitled background/objectives, by specifying relevant regulatory requirements, for example.

Other relevant rules: details of operating procedures with related content are given under this section. Such details should be provided with great care. On the one hand, understanding of the context is increased by specifying further literary sources; on the other hand, more maintenance is required in the event of modifications.

Validity: the scope already defined on the cover sheet is further substantiated in the area of validity, e.g. by naming the manufacturing facility responsible for the content.

Definitions/abbreviations: new terms are defined here and given abbreviations, if appropriate. These abbreviations can then be used in the text.

2.2.5 Implementation section

The processes to be regulated are described in the implementation section.

The implementation section can be further structured depending on the contents of the operating procedure.

2.2.6 Appendices

The implementation section can be completed by appendices, e.g. checklists or forms which facilitate the processing of a procedure.

Interchangeable appendices receive a version number with date. These appendices (e.g. forms, signature lists can be updated if required, provided that
they are still consistent with the contents of the operating procedure.

The appendices are not included in the page numbering system for the operating procedure.

2.2.7 Distribution list

The distribution list itemises the sections to which the operating procedure must be distributed. The distribution list consists of the "compulsory" and "for information" recipients (see Appendix 1).

2.2.8 Receipt

The receipt is used as documentary evidence that the recipient has received a copy (original copy) (see Appendix 2).

2.3 Implementing an operating procedure

The following steps must be worked through before an operating procedure is implemented.

  • Compilation
  • Checking
  • Approval

2.3.1 Compilation

New operating procedures should be compiled by a specially trained employee, i.e. an employee who is concerned in practice with the regulations of the operating procedures and is familiar with the workflows described therein.

To co-ordinate a new operating procedure or a procedure to be reviewed, a draft must be compiled and distributed in a new commenting procedure for the purpose of attracting comments. Those participating in the commenting procedure are all the sections who will subsequently be affected by the contents of the operating procedure.

The compilation is documented with the appropriate signature together with the name and role of the member of staff as well as the date that the operating procedure was signed.

2.3.2 Checking

After the text has been compiled, the operating procedure and its contents must be formally checked.

The technical check must be conducted by a competent person who works independently of the compiler. Compliance with the design and format details will be formally checked by the quality assurance department.

The analysis can be conducted by several persons depending on requirements (e.g. for operating procedures which need to be enforced for several sections). The check is documented with the appropriate signature together with the name and role of the checker as well as the date that the operating procedure was signed.

2.3.3 Approval

Operating procedures must be approved by the person responsible before they are used.

The approval requires the suitability of the operating procedure to be checked and is granted by the person(s) who are responsible for the regulatory part of the document, e.g. quality assurance unit, head of production or head of quality control)

The approval is documented with the appropriate signature together with the name and role of the checker as well as the date that the operating procedure was signed.

2.3.4 Implementation

An operating procedure is considered to be in force, when all required signatures - compilation, checking, approval have been added and when the validation date has been reached.

2.4 Operating procedure training

To enable an operating procedure to be implemented, the employees concerned must know and understand the contents and be able to use them. To this end, training is provided on the operating procedure.

The responsibility for compiling an operating procedure lies with the manager of the department to which the operating procedure essentially relates. The department manager should plan and carry out the necessary training measures.

Newly compiled or revised operating procedures are explained as part of the initial training process. The scope of the initial training depends on the contents of the procedure and the group of recipients. The training measures can range from simply reading to practical demonstrations at the site of the event. Training on operating procedures must be documented.

2.5 Administration of operating procedures

The history of an operating procedure is accompanied by various administrative actions. These actions might include:

  • Compiling/maintaining overview lists in valid operating procedures
  • Numerical assignment
  • Monitoring the approval cycle
  • Identifying/distributing operating procedures
  • Monitoring the checking procedure
  • Archiving

Depending on how an area is organised, operating procedures can be administered decentrally (e.g. throughout the company) or centrally (e.g. a documentation point/an employee appointed for SOPs).

2.5.1 Numbering and identification

2.5.1.1 Numbering

The operating procedures are numbered according to the following structure:

AA -

BB -

111 -

22

AA: Compiling area

 

BB: Subject area

   

111: Serial number

     

22: Version

Each number may only be assigned once. The numbers are assigned by the administrative point.

2.5.1.2 Identification

The production of copies which are necessary for the further distribution of the operating procedure must be carried out under controlled conditions. The relevant version of the operating procedure is identified as followed in accordance with its status:

  • Draft
  • Original
  • Original copy
  • Copy for information

The original is the copy of the operating procedure that bears the original signature from the approval process. The original is identified with the word "original" (in red) stamped on each page of the operating procedure. Pre-printed paper is used for this. If an original is replaced by a new version or is withdrawn, it must be identified as such by stamping the word "invalid" on the cover sheet.

The original copy is a copy of the original. It is identified by printing the word "original copy" (in red ink) on each page of the operating procedure. Pre-printed paper is used for this.

A copy for information only is not registered and is not subject to the change procedure. The recipient of this informative copy is responsible for keeping it up to date. It is identified by printing the "copy for information only" (in red ink) on each page of the operating procedure.

A draft operating procedure does not show any compulsory work principles and is used to co-ordinate the contents of a new or revised operating procedure. It is identified by printing the word "draft" (in red ink) on each page of the operating procedure.

2.5.2 Distribution

The operating procedure is distributed to the area/persons listed in the operating procedure distribution list.

Distribution must be carried out in good time before the validity date is reached and must be documented. The recipient confirms on the receipt that they have obtained a new or consecutive version or withdrawal or even destruction of the previous, now invalid version.

2.5.3 Archiving

The original version of the operating procedure and any replaced appendices as well as all checking forms are archived in the administrative section.

The receipts are administered together with the distribution list. The history sheet (see Appendix 4) is then archived together with the operating procedure that was withdrawn.

The archiving time period for operating procedures is 15 years.

2.6 Checking operating procedures

Operating procedures must be checked to ensure that they are up to date at regular intervals.

Operating procedures must be changed immediately if the contents are changed. It will, however, be necessary to carry out a check after two years have passed.

A checking procedure can have the following results:

  • "still up to date":
    The operating procedure will remain up to date for the next time interval.
  • "for review":
    The operating procedure will be reviewed; a consecutive version will be generated.
  • "for withdrawal"
    The operating procedure will be withdrawn.

The results of checking an operating procedure are documented on an associated form, the distributees are informed of the result and the form is archived.

It can be established when checking an operating procedure that it is necessary to change and update the contents and adapt them to the conditions which have been changed since the procedure was first compiled.

2.7 Changing operating procedures

Changes in relation to the previous version will be listed as key points in the index of changes.

Changing or updating an operating procedure will also entail a consecutive version with a new version number. The version numbering is a part of an operating procedure numbering system. In the event of more fundamental changes, it can also be necessary to compile a new operating procedure. The decision of whether or not a consecutive version or a new operating procedure should be compiled is taken by the compiler.

Changes made throughout the history of an operating procedure are illustrated in an overview, the history sheet (see Appendix 4). The history sheet lists all changes between each version, including the appendices, in chronological order. The history sheet is not a part of an operating procedure but is centrally administered in the administrative unit.

If changes are made, a consecutive version of the operating procedure is generated. When the consecutive version is implemented, the now invalid original of the previous version is marked as invalid and archived.

If changes are made to operating procedures which have contents which are relevant to the authorities, (e.g. specifications of a manufacturing process or analytical procedure), the specifications of the change control program must be considered.

2.8 Giving training on an operating procedure

Operating procedures which have become invalid and which will not be replaced by a different operating procedure or consecutive version must be withdrawn from circulation in writing. This must be done using a form.

Operating procedures withdrawn from circulation are destroyed by the sections/persons listed in the operating procedure distribution list. The destruction is documented and the department administering the operating procedures informed.

End of operating procedure

Figure 15.D-5 Appendix 1 to SOP "Compilation and administration of operating procedures"

Company name

Logo

Appendix 1 to SOP "Compilation and administration of operating procedures"

Distribution list

SOP no. QA-AD-001-01

valid from 1. January 2000

Page x of y

Replaces appendix no. ---

Compulsory for

Production:
Manufacturing company 1
Manufacturing company 2
Manufacturing company 3
Central weighing area
Documentation

Quality control
Laboratory 1
Laboratory 2
Laboratory 3

Documentation point

Formulation:
Development laboratory 1
Development laboratory 2
Development laboratory 3
Development laboratory 4

Quality assurance:

Documentation management

For information:

Central documentation

Figure 15.D-6 Appendix 2 to SOP "Compilation and administration of operating procedures"

Company name

LOGO

Appendix 2 to SOP "Compilation and administration of operating procedures"

Receipt

SOP no. QA-AD-001-01

valid from 1. January 2000

Page x of y

Replaces appendix no. ---

I hereby confirm receipt of the operating procedure

>Title of the operating procedure (number of the operating procedure)<

________________________________________________________
date, signature

Figure 15.D-7 Appendix 3 to SOP "Compilation and administration of operating procedures"

Company name

LOGO

Appendix 3 to SOP "Compilation and administration of operating procedures"

Checking the operating procedure

SOP no. QA-AD-001-01

valid from 1. January 2000

Page x of y

Replaces appendix no. ---

The operating procedure was checked with the following results:

 

"still up to date":

 

"for review":

 

"for withdrawal"

Reason for withdrawal

________________________________________________________
signature of the checker, date

________________________________________________________
signature of the approver (for withdrawals only), date

Figure 15.D-8 Appendix 4 to SOP "Compilation and administration of operating procedures"

Company name

LOGO

Appendix 4 to SOP "Compilation and administration of operating procedures"

Index of changes

SOP no. QA-AD-001-01

valid from 1. January 2000

Page x of y

Replaces appendix no. ---

Version no.

Reason for change

Valid from

01

New compilation

 

01.01.1999

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

Summary

Operating procedures are instructions for working. The contents must therefore be described in a brief, clear and comprehensible manner.

The addressee of an operating procedure is the member of staff who requires instructions or explanations on how to process a certain subject. In addition, operating procedures are also used to demonstrate internally (e.g. internal auditors) and externally (e.g. inspectors from authorities) that the specified processes are being carried out in a focused manner.

To enable operating procedures to be used sensibly and effectively, certain preconditions must be fulfilled. The operating procedure must be compiled, enforced, understood and trained.

A clearly structured layout and a uniform format or layout for all operating procedures increases readability and comprehension.

Operating procedures must be checked regularly throughout their life cycle and the contents adapted to changes in circumstances if required. The administration of operating procedures is facilitated by an intelligent numbering system.

Operating procedures are an important component of the GMP documentation and must be archived.



Рейтинг@Mail.ru Rambler's Top100