Qualification and validation

Details about the qualification and validation in the pharmaceutical analysis. Definitions, types and protocols of the qualification and validation

1. QUALIFICATION AND VALIDATION K. Archana M. Pharm ( Analysis)

2. Definition The technology transfer is a critical step in the life cycle of any pharmaceutical product that involves many steps. USFDA validation guidance issued in 2011 specified three major stages of process validation that must be satisfied to consider the process validated. “Qualification is defined as action of providing that equipment or system are properly installed, work correctly and actually lead to expected results.”

3. Qualification Installation qualification Operational qualification Process qualification Performance qualification Together qualification assures consistency of manufacturing. Critical process parameters are recorded and analyzed to ensure critical quality attributes. In process qualification the process design is evaluated to determine if the process is capable of reproducing commercial manufacturing. Well trained staff, thorough records helps the ongoing protection from process faults and quick recovery. Process qualification vital component is process qualification protocol(PPQ). PPQ is important for maintain production standards with in the organization.

4. The protocol includes: Facility, Utilities Equipment, Personnel Manufacturing process Control protocols and monitoring software Validation master plan GMP risk analysis Validation protocol, Validation analysis Summary of deviation and issues.

5. VALIDATION Validation of a process ensures production of drugs with reproducible quality. Validation is an ongoing activity that covers the development, operation and maintenance. Validation was first proposed by two FDA officials named Ted byers and Bud Loftus in 1970 to improve the quality of pharmaceuticals. Initially it was process controlled but quickly associated to applied processes such as environmental control, media fill, equipment sanitization and purified water production. Regulation of raw materials, production procedures, testing of final product. Validation protocol must be followed, maintained up to date by trained personnel and inspected regularly.

6. Reasons for validation Quality assurance : Quality cannot be assured daily by quality control testing. Validation checks the accuracy and reliability of the system or a process to meet definite criteria. A successful validation provides high assurance. Economics: Decrease in sampling and testing procedures on successful validation. This leads to cost saving benefits. Compliance: For compliance cGMP’s validation is necessary and essential.

7. Phases of validation Pre validation qualification : occurs during R&D Pilot plant studies, small batches, scale up studies Attention must be paid to the details including material handling, storage procedures, finished product review, equipment installation and verification, distribution of final product. Process validation phase: Through out the manufacturing process Decreases the mistakes and recalls. Trained personnel to follow protocols and SOP’S All materials to be handled from the staring point to end point of the production in the same manner. Validation Maintenance phase : Maintenance phase is when the process is running smoothly and consistently at the same time. No know problems, but review of SOP’S and changes to be documented. Audit and audit reports to be maintained, refreshing training to the personnel with the news specifications.

8. Process validation

9. Types of process validation

10. Validation documentation Change control : The need for action that would ensure and document that the system is maintained in a validated state. Validation master plan : Summarized document that describes the whole project including quality aspects of the project. Validation protocol : VMP is ready protocol will be developed. General information Objective Prevalidation activities List of equipment and qualification Facilities qualification Flow charts Manufacturing procedure narrative Critical processing parameters Sampling tests Acceptance criteria

11. Approved Regulatory agencies EU: Chapter 4 guidelines that require transfer protocols, policies, procedures Chapter 6: testing methods in transfer technology Chapter 7: Written content, documents FDA: Technology transfer “Quality Agreements” Required details of starting materials, procedures, protocols etc from starting point to end point WHO: Published guidelines in 2011.

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