Validation

Pharma Group Baltic has own validation specialists and measuring/testing equipment that allows to conduct most kinds of qualification/validation activities for pharmaceutical industry in accordance with international, European and different national normative GMP requirements and standards:

Validation Activities


Normative requirements

Annex 15 to the EU Guide to Good Manufacturing Practice:

"...Design Qualification (DQ)

9. The first element of the validation of new facilities, systems or equipment could be design qualification (DQ).

10. The compliance of the design with GMP should be demonstrated and documented.

Installation Qualification (IQ)

11. Installation qualification (IQ) should be performed on new or modified facilities, systems and equipment.

12. IQ should include, but not be limited to the following:

(a) installation of equipment, piping, services and instrumentation checked to current engineering drawings and specifications;

(b) collection and collation of supplier operating and working instructions and maintenance requirements;

(c) calibration requirements;

(d) verification of materials of construction.

Operational Qualification (OQ)

13. Operational qualification (OQ) should follow Installation qualification.

14. OQ should include, but not be limited to the following:

(a) tests that have been developed from knowledge of processes, systems and equipment;

(b) tests to include a condition or a set of conditions encompassing upper and lower operating limits, sometimes referred to as "worst case" conditions.

15. The completion of a successful Operational qualification should allow the finalisation of calibration, operating and cleaning procedures, operator training and preventative maintenance requirements. It should permit a formal "release" of the facilities, systems and equipment.

Performance Qualification (PQ)

16. Performance qualification (PQ) should follow successful completion of Installation qualification and Operational qualification.

17. PQ should include, but not be limited to the following:

(a) tests, using production materials, qualified substitutes or simulated product, that have been developed from knowledge of the process and the facilities, systems or equipment;

(b) tests to include a condition or set of conditions encompassing upper and lower operating limits.

18. Although PQ is described as a separate activity, it may in some cases be appropriate to perform it in conjunction with OQ..."