Incorporating Q8, Q9, Q10 into good manufacturing practices (GMP), guidance on process validation, health based exposure limits covering cleaning validation and computerized system validation are the emphasis of current and future pharma manufacturing operations, stated Krishna Mohan, Asst. GM, Corporate QA and SME Validations,  Aurobindo Pharma.

While validation is the process of establishing documented evidence to provide a high degree of assurance that a specific process will consistently produce a quality product,  qualification is seen as an action to prove any equipment works correctly and leads to the expected results, he added.

At the recently concluded day-long DIA conference, Mohan who delved on the ‘Regulatory views pertaining to qualification/validation pointed out that any procedure, process, equipment, material, activity or system needs to actually generate correct results.

With regard to qualifications the focus is on  process and laboratory equipment. In the case of validation, it is process, cleaning, computerized system and sterile. The global regulatory authorities have a specific importance for each of these, said Mohan.

Providing a peek into the current regulatory views, he said that while US FDA views qualification as a subset to validation which is a traditional approach to provide a documented evidence of installations with specifications among others to maintain critical process parameters repeatedly and reliably. European Union guidelines too also provide similar rules with a five-step process comprising: design, installation, maintenance, operational and performance qualification. This is only to verify plant environment, instrument calibrations and routine maintenance.

Coming to Lab Equipment Qualification, the regulators call for good automation manufacturing practice (GAMP) and good practice guide (GPG)  software driven approach, continuum of computerized lab system USP (United States Pharmacopoeia) instrument driven approach, qualification for complex instruments and calibration for simpler instruments, he said.

The process validation for FDA & EU traditionally for each product is based on prospective, retrospective and concurrent systems in minimum three batches with use of statistical tools wherever required.

Process validation is evaluation of data, from the design stage through commercial production to ensure  consistent  delivery of  a quality product.

Further, the Process Design is evaluated to determine if it is capable of reproducible commercial manufacturing. The next step is to make sure of  continued process verification which is an ongoing assurance gained during routine production.

In the area of cleaning validation, US FDA insists on 21 CFR part 11, electronic signatures and e: records. EU measures risk management. But Health Canada specifically calls for validation activity in three phases. The first phase covers pre-validation or the qualification phase. Second phase deals with  process validation. Third phase focuses on validation maintenance.

Similarly, ICH - Q8, Q9, Q10 calls to identify the scope and extent of verification, qualification and validation activities under Knowledge Management and Quality Risk Management.

Mohan further contended that additional testing and inspection alone would not improve quality unless it is built-in. This is because science is no longer isolated but exists across the life cycle of the product/process within a Quality Management System, he said.