30 COMMON ACRONYMS IN PHARMACEUTICAL VALIDATION, WHAT DO THEY STAND FOR?

Validation is an indispensable element in the pharmaceutical industry, the validation process requires strict adherence to rules and adherence to standard concepts and regulations. Below are 30 common acronyms and concepts that are often referred to when qualifying pharmaceutical products.

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1. DQ: Design Qualification

2. IQ: Installation Qualification

3. OQ: Operational Qualification

4. PQ (P1Q): Performance Qualification

5. PV (P2Q): Process Qualification or Process Validation

6. URS: User Requirement Specification

7. FAT: Factory Acceptance Testing

8. SAT: Site Acceptance Tests

9. cGMP: Current - Good Manufacturing Practice

10. EU-GMP: European Union - Good Manufacturing Practices.

11. WHO-GMP: World Health Organization - Good Manufacturing Practices.

12. PIC/S-GMP: Pharmaceutical Inspection Co-operation Scheme.

13. GSP stand for "Good Storage Practices".

14. GDP: Good Distribution Practices.
15. GPP: Good Pharmacy Practices.
16. GLP: Good Laboratory Practice.

17. CFR: Code of Federal Regulations.

18. ISPE: The International Society for Pharmaceutical Engineering.

19. GAMP: Good Automatic Manufacturing Practice.

20. GAMP® 5: It is in reference to a guidance document entitled GAMP®5: A Risk-Based Approach to Compliant GxP Computerized Systems. This document is published by an industry trade group called the International Society for Pharmaceutical Engineering (ISPE) based on input from pharmaceutical industry professionals.

21. FDA: U.S. Food and Drug Administration.

22. CSV: Computer Systerm Validation.

23. SCADA: Supervisory control and data acquisition.

24. "R.A" (μm) Arithmetical mean roughness value.

25. "R.Z" stands for mean roughness depth. 

26. CE: European Conformity

27. ATEX: An explosion-proof certificate , referenced to the European Directive 2014/34/EC on explosion-proof systems on electrical and mechanical equipment, components and systems.

28. PED: Pressure Equipment Directive 

29. VMP: Validation Master Plan.

30. HVAC system qualification protocol: Heating, Ventilating and Air Conditioning system qualification.

 

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