Qualification and Validation

 

                                                       

                                                          Qualification and Validation

1- In accordance with GMP, each pharmaceutical company should identify what qualification and validation work is required to demonstrate that it is critical aspects of their particular operation are controlled.

2- Key elements of the company's qualification and validation program should be clearly defined and documented in the master validation plan.

3- Qualification and validation should create and provide documentation proof that:

a) Premises, support services, equipment and processes were available designed in accordance with GMP requirements (design certificate, or DQ);

b) Premises, supporting engineering networks and equipment were built installed in accordance with their design specifications (installation qualification or IQ);

c) The premises, support facilities and equipment functioned in accordance with their design specifications (operational qualification or OQ);

d) A specific process will consistently produce a product meeting its predetermined specifications and quality attributes (process validation or PV, also called performance qualification or PQ).

4- Any aspect of operations, including significant changes to premises, equipment, facilities or processes that may affect product quality, directly or indirectly should be qualified and validated.

5- Qualification and validation should not be considered as one-off exercises. An ongoing program should follow their first implementation and should be based on an annual review.

6- A commitment to maintain ongoing validation status should be given in relevant company documentation such as the quality manual or master validation plan.

7- Responsibility for performing validation should be clearly defined.

8-Validation studies are an essential part of the GMP and should be carried out in accordance with predetermined and approved protocols.

9- A written report summarizing the recorded results and conclusions should be prepared and stored.

10- Processes and procedures should be established based on the results validation performed.

11- It is extremely important that special attention is paid to the validation of analytical test methods, automated systems and cleaning procedures.