gmp
Welcome to the website about GMP Guideline

The Good Manufacturing Practices Guide describes general principles that, can help to organize production in accordance with GMP. The practice of organizing production is practically not described in the manual, it is described in the literature, which you can find on this site. If you did not find the answer on the site, you could ask your colleagues for advice on the forum.

Good manufacturing practice requirements vary in different countries.    On this site, you can find the requirements in USA, EU, UK, Australia, Canada, UA, RU, WHO.

The information on this site is structured into the following sections:

The business management practice section describes a pharmaceutical company management system based on a process approach.

The marketing section is aimed at identifying market needs and opportunities.

Market needs are met by products that are developed in research and development.

After product development, a production capacity project is being developed. Design of equipment and facility is governed by good engineering practice (GEP).

Procurement, storage of raw materials, production, quality control is governed by the requirements of good manufacturing practice (GMP).

Storage and distribution are governed by Good Storage Practices (GSP) and Good Distribution Practices (GDP)

Automation of logistics, production, quality control and quality assurance, is regulated by the Good Automated Manufacturing Pracice (GAMP).

Good manufacturing practice requirements are described in detail in the following charters:
1.
Pharmaceutical quality system
2.
Персонал
3.
Clean rooms
  • Guideline Requirements
  • Engineering
  • Heating, Ventilation, Air Conditioning
  • Qualification
  • Monitoring
6.
Documentation
Qualification and Validation
RA
Risk Analysis
DQ
Design qualification
IQ
Installation Qualification
OQ
Operation qualification
PQ
Performance qualification
PV
Process validation
FV
Validation of sterile filtration
CV
Cleaning Validation
CSV
Computerized systems validation
MV
Method Validation