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Technical documentation

Here you will find answers to the following questions:

  • What does technical documentation have to do with GMP?
  • Which components make up the technical documentation in the GMP context?
  • How can extensive technical documentation be handled?

1 Necessity

Technical documentation comprises the recording, organisation, and archiving of technically-relevant documents and data, as well as their provision for information purposes (dtv, 1984). It is used to present procedural sequences and general technical conditions in a reproducible and up-to-date form. What does technical documentation have to do with GMP? Chapter 4.26 of the EU GMP Guideline states: "There should be written procedures and the associated records of actions taken or conclusions reached, where appropriate, for:[...], equipment assembly and calibration, maintenance, [...]. "Clear operating procedures should be available for major items of manufacturing and test equipment. "[EU GMP Guideline, chapter 4.27].

In order to satisfy the requirements of the EU GMP Guideline, the technical documentation is just as necessary as the qualification of rooms and facilities. Analogous to the basic principles of the documentation contained in chapter 4 of the EU GMP Guideline, the technical documentation is also a part of the quality assurance. If no technical documentation exists, it will not be possible either to install, qualify and operate facilities or calibrate, repair or maintain them. Important prerequisites for the usefulness of the technical documentation are: Absence of errors, relevance to the current situation, clarity, unambiguity, completeness and comprehensibility.

The technical documentation is for the most part compiled by the machine suppliers. Incomplete, incorrect or defective documentation should be rejected. To avoid this situation, it is advisable that the manufacturer of the machine has the documentation checked, approved and released by competent authorised persons prior to delivery. For more extensive documentation, it may be expedient for the users to receive instruction from the supplier, e.g. as part of training courses. In the interests of comprehensibility and bearing in mind the range of users, it is worth requesting that overseas manufacturers provide the most important sections in the local language.

2 Scope and content

The documents in figure 1 are an important part of the technical documentation (also see general requirements, chapter 4 EU GMP Guideline).

Figure 1 Contents of the technical documentation
[EU Guideline]

Content of the technical documentation

  • Technical specifications
  • Process descriptions
  • Operating and assembly instructions
  • Wiring diagrams and construction drawings
  • Test protocols
  • Maintenance schedules
  • Calibration documents
  • Machine log books

In the interests of clarity, easy handling of documentation, and reduced search times, all technical documents should be structured in the same way.
Figure 2.

Figure 2 Possible organisational system for technical documentation

contains an example of this:

A good way of standardising the technical documentation is to work out checklists (see figure 3, figure 4, figure 5). These lists are helpful when specifying new facilities and they simplify the review of the technical documentation during qualification.

Figure 3 Checklist - technical documentation (part 1)  

Basic documents for the mechanical part of a facility

Document

Available
yes/no

Documents requiring authorisation after construction

Technical specification

 

General description of facility with drawings and function diagram, abridged form

 

List of components of a facility, machine, equipment or system

 

Assembly and layout plans that explain interaction with existing facilities/equipment (on-site requirements, connection requirements).

Equipment drawings including data for on-site connections (energy, utilities, drainage) and other on-site equipment as necessary (platform, stair, balustrade, etc.)

 

Instructions for bringing in large components (into building)

 

(*)

Facility documentation upon delivery

 

Installation plans, layout plans and electrical plans must be available both in paper form and on data media (diskettes: DWG or DXF file formats).

 
 

Detailed list of the energy and utilities supplied in accordance with the equipment specification

 
 

List of operational parameters/tolerances of these components; data on limits (pressure, temperature, variation limits)

 
 

List of components and equipment used, structured according to assemblies, including full description (model number, material, type, size, manufacturer, etc.) and schematic drawing of installation location (overview of assemblies)

 
 

Comprehensive documentation (materials used, requirements for materials, etc.) of parts in the facility that come into contact with products, auxiliary modules and the controls

 
 

Machine drawings/equipment drawings

 
 

Contractual documents with technical specification to subcontractor

 
 

List of all parts that come into contact with the product

 
 

Clearance certificate for parts that come into contact with products

 
 

List of operating instructions and instruction manuals

 
 

Detailed operating instructions

 
 

Abridged version of operating instructions, max. 1-2 DIN-A4 pages

 
 

Maintenance manual for entire facility, partial facilities and components

 
 

Spare/wear parts list

 
 

Bill of materials with original manufacturer's specification

 
 

List of preventative maintenance and repair measures

 
 

TЬV (technical inspection authority in Germany)/other certificates (certification of construction and water pressure inspection; final acceptance of safety equipment; certificate of compliance for cryogenic plant, liquefier, etc.)

 
 

Documentation of pressure and leak tests for components, chambers, condensers, intermediate valves, cryogenic systems, etc.

 
 

Record of function tests (factory acceptance test, FAT) at manufacturer's premises

 
 

Characteristic diagrams (e.g. of circulatory pumps)

 

(*) In the first column, the documents requested by the suppliers must be ticked.

Figure 4 Checklist - technical documentation (part 2)  

Basic documents for the electrical and control element of a facility

Document

Available
yes/no

Documents requiring authorisation after construction

Technical specification (e.g. following ISO/DIN 3694 and in conjunction with mechanical element)

 

Block circuit diagram/diagram of facility with designation of utilities

 

R&I plans

 

Front panel views, to scale

 

Equipment layout plans, to scale

 

Schematic or operating circuit diagrams

 

List of measuring points including definition of quality-relevant measuring points by contract giver/list of sensors

 

Measuring point sheets

 

Terminal diagrams

 

Cable lists

 

Equipment parts lists

 

(*)

Facility documentation upon delivery

 

Installation plans (strip maps) for decentralised assembly, requirements for strip maps

 
 

Application software on 3,5" diskettes

 
 

Documentation of process control with comments on steps (in relevant language)

 
 

Functional description of user software

 
 

Detailed documentation of PC and visualisation application programming

 
 

Version status of firmware (PLC)

 
 

Description of development environment/dev. tool - data on system and name of programming system

 
 

Commented source code (in relevant language) or viewing rights

 
 

Storage of source code in a neutral location

 
 

Assignment list (PLC only)

 
 

Version number of software in the code

In the event of a change on our part: notification to supplier

 
 

Input/output memory map for PLC

 
 

Interface specifications

 
 

Alarm list with structure: effect, cause, remedy

 
 

Operating manual/function description (hardware)/original documentation of supplier

 
 

List of equipment parameters

 
 

Qualification of measuring circuits

 
 

Operating instructions/start-up instructions

 
 

Maintenance instructions (calibration instructions, if required)

 
 

Spare parts list

 
 

Electrical acceptance report at manufacturer responsible for production of facility parts (sub-contractor)

 
 

EMC test protocols for equipment and facilities (electromagnetic compatibility)

 
 

CE certificate for facility

 
 

Instrument manuals

 
 

Installation certifications (e.g. according to VDE)

 
 

Installation instructions, software

 
 

Installation instructions, hardware

 

(*) In the first column, the documents requested by the suppliers must be ticked.

Figure 5 Checklist - technical documentation (part 3)  

Additional documents for qualification of facilities

Document

Available
yes/no

(*)

Mechanical element

 

List of machine, equipment and system drawings, with confirmation that these correspond with the actual installation

 
 

Test procedures and results of the review to determine completeness and correct assembly

 
 

Installation certificate (certifying correct assembly and on-site wiring between control cabinet and machine incl. plan and checklists)

 
 

Special inspection reports on the quality of workmanship (e.g. weld seam protocols)

 
 

Certification of surface quality (e.g. surface roughness measurements)

 
 

Certification of correct installation of sterile filters (check for leakage flow)

 
 

Descriptions of materials used (e.g. raw material, condensers, adjusting plates, reinforcement profiles, auxiliary welding materials)

 
 

Electrical and control element

 

Input/output diagram of software modules

 
 

Confirmation that completeness check on documents delivered by sub-contractors has been carried out

 
 

Detailed description of utilities used"

 

(*) In the first column, the documents requested by the suppliers must be ticked.

A great deal of information, usually drawings, but also increasingly operating instructions, bills of materials, etc. is being stored on data media. In order to ensure that the available documents are compatible and therefore useful, the supplier and customer must arrange in good time which data medium and data formats should be used. The Internet provides an interesting option in this case as online access to the supplier's server means that the necessary information can be downloaded directly with the following benefits: the information is up-to-date and no administrative effort is required.

3 Administration of the technical documentation

Not least due to ISO certification (see chapter chapter 1 Quality Management), there is widespread acceptance amongst manufacturers of machines that equipment is incomplete where appropriate documentation is lacking. Many malfunctions and ambiguities that lead to questions being raised as to whether the equipment should be accepted or not can be avoided by providing complete technical documentation. The scope of the technical documentation increases with the complexity of the machines. Nowadays, it is not unusual for as many as twenty folders of equipment documentation to be required, and so the necessity to administer and tend of this mass of paperwork and data as well as develop suitable systems to deal with it, is unavoidable.

A system for technical documentation is characterised by established archiving modalities (see figure 6).

Figure 6 Archiving modalities

Archiving modalities

  • Uniform structure
  • Clear identification
  • Change control
  • Version management
  • Access control
  • Defined responsibilities
  • Established in a SOP and training of staff

An example of uniform structuring is shown in figure 2.

The definition of an identification system (e.g. using code numbers) is particularly important, especially in the case of centrally archived systems. However, defined numbering is also highly recommended where decentralised storage systems are used and where the document administration is to be carried out electronically. For engineering drawings, the introduction of a "descriptive" numbering system is recommended.

Change control: (see chapter 19.C Change control) The effort required to keep everything up-to-date on an ongoing basis cannot be underestimated and a pragmatic approach should therefore be adopted. For example, the frequency of the updates may be dependent on the quality relevance of the technical change and secondary changes can be dealt with by cyclical updates, e.g. once a year. If the change affects the quality of the product the technical documentation must be modified immediately, irrespective of whether the change is planned or is made as a result of a malfunction.

Figure 7 shows the relationship between the cyclical updates and changes that are subject to mandatory requalification for qualification, technical and calibration documentation and maintenance schedules.

Figure 7 Change control

For technical documentation, version management is a prerequisite for the availability of clear and up-to-date information. For documentation stored on data media, particularly software documentation, this is essential.

Clear arrangements regarding access control and responsible persons must be made. To prevent copies being made that are uncontrollable and therefore not subject to updates, the original documentation must be accessible only to authorised individuals and any lending/borrowing must be documented (see figure 8). In practice it is recommended that one or several working copies, subject to updates, are handed out (see chapter 15.D.8 Administration).

Figure 8 Administration sheet for working copies

4 Log book

"Log books should be kept for major or critical equipment recording, as appropriate, anyvalidations, calibrations, maintenance, cleaning or repair operations, including the dates andidentity of people who carried these operations out." (EU GMP Guideline, chapter 4.28) Chapter 4.29 of the EU GMP Guideline additionally states that "Log books should also record in chronological order the use of major or critical equipment and the areas where the products have been processed."

Figure 9 Contents of log book

Contents of log book

Documenting log books in chronological sequence:

  • Operation and use
  • Cleaning and sterilisation
  • Maintenance, repair, changeover
  • Changes, conversion
  • Qualification, calibration, validation

Log books must be kept for:

  • Equipment, machines, facilities
  • Ventilation systems, purified water systems
  • Rooms

Log books must be kept and stored on-site, i.e. in the room or at the facility. Following CFR 211.180, log books must be retained for at least 1 year after the expiration date of the batch manufactured on the facility. However, to reduce administrative expenditure it is recommended that a standard retention time for log books be defined, e.g. 6 years (expiration date of the medicinal product batch: 3 years, plus safety margin: 3 years). This ensures that log books will still be retained once the machines and rooms have been decommissioned.

Entries must be made on-site in chronological order by the person carrying out the task(s). The entries must be confirmed by the signature of another person who is overseeing the task and must be made promptly, i.e. when the current task is being carried out - the signing may be carried out after completion. Entries and changes in the documentation must be carried out in accordance with the requirements of the EU GMP Guideline. (See chapter chapter 15 Documentation, (see chapter 15.B GMP-conforming documentation).

In the interests of simple handling, it is recommended that a standard log book is compiled for use in all the necessary areas. The assignment of log books to facilities or rooms must be facilitated through clear labelling. The individual pages of the log book must be consecutively numbered. An example of a general purpose log book can be found in figure 10 Log book (example). Special features of an area may be recorded in the log books using the "facility-specific area" column.

Figure 10 Log book (example)

Summary

If no technical documentation exists, it will not be possible either to install, qualify and operate machines and facilities or to calibrate, repair or maintain them.

It is recommended that the same standards that apply for pharmaceutical documentation are adopted for the handling of technical documentation.

There is no cost-free solution for a technical documentation system.

It is not sufficient simply to introduce systems and expect them to take care of themselves. The technical documentation must be updated during change control procedures. The success (or failure) of the system depends on how well the organisation embraces it, lives with it and develops it further.

Log books for machines, rooms and systems must be used to document all work in chronological order.



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