CQV Part 1: A Critical Element in the Pharmaceutical, Biotech and Medical Device Industries

Commissioning, Qualification, and Validation (CQV) is a crucial process in the pharmaceutical industry that ensures that facilities, equipment, and processes are designed, installed, tested, and maintained to produce high-quality products that meet regulatory requirements. The essential elements of CQV in the pharmaceutical industry include:

Commissioning: Is a systematic approach that involves verifying and documenting that the facilities, systems and equipment are installed, tested, and operate according to the user requirements and design specifications.  This can include reviewing equipment manuals, conducting factory acceptance tests (FAT), and site acceptance tests (SAT) to ensure that the equipment and systems function properly.

Qualification: This involves documenting that the equipment, facilities, utilities, and processes are capable of consistently producing product that meets the project user requirements, GMP guidelines, and specified quality standards. Qualification can include installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).

Validation: This involves demonstrating that the manufacturing process is capable of consistently producing products that meet the specified quality standards and product attributes. This includes process validation, which manufactures and packages actual product to ensure the entire process is capable of repeatably producing product that meets the required quality standards and product release criteria.   Cleaning validation, which ensures that the cleaning process is effective in removing both product and cleaning agent residues that would impact product quality is another critical step in the validation process.

Documentation: All CQV activities must be documented to demonstrate compliance with regulatory requirements. This includes developing and executing all validation protocols, test plans, standard operating procedures (SOPs), deviations and all necessary reports.

Change Control: CQV processes should be integrated with a robust change control process to ensure that any changes to equipment, facilities, or processes are documented, reviewed, and approved as part of the ongoing process of meeting all regulatory requirements.

Training: Personnel involved in CQV activities must be adequately trained on the procedures, policies, and regulatory requirements related to the equipment, facilities, and processes they are validating to ensure that they have the knowledge and training necessary to adequately perform their roles in the CQV process.

Overall, CQV is critical to ensuring that pharmaceutical products are produced consistently and meet the required quality standards. The process must be carefully planned, documented, and executed to comply with regulatory requirements and ensure the safety and efficacy of the products.

While this blog discussed the various elements of CQV, coming up in Part 2 of this 3-part series we will discuss some of the common challenges associated with CQV and how to overcome them. If you’d like to speak with a CQV subject matter expert, email us at [email protected].


Read CQV Part 2: Common Challenges in the Pharmaceutical, Biotech and Medical Device Industries

Read CQV Part 3: Overcoming Challenges in the Pharmaceutical, Biotech and Medical Device Industries