Validation Processes in Pharma Manufacturing

When a pharma company lacks group work orientation, then blunders and mistakes become more periodic.

What happens when you’ve tabulated data, but no proper analysis to chart out user requirement specifications?

Perhaps, it’s become harder for the project team to conceptualize the functional design process and put down the details of sequential processes. In the end, with messy scenarios, there can be neither proper follow ups nor orderly initiatives for project implementation.

Obviously, for the sake of production capacity expansion, it becomes essential to upgrade an existing facility, with adequately designed and understood equipment, HVAC systems and containment controls. But then, any scarce equipment qualification protocols, weak summaries with no rationale, deficient robustness studies or lack of effective risk assessments can delay the progress of a project and hamper the required validation processes.

In pharma companies, where top managers cling on to traditional methods and random thinking, then there will be possibilities of common errors even after execution of a project or completion of validation work with incoherent results and missing tracking reports and data analysis.

Since, validation is an important part of quality assurance; therefore, responsible persons should take various steps and other relevant considerations.

In one case, a pharma company got the manufacturing processes validated in terms of cGMP, but then, on a closer scrutiny, respective departments were lacking sufficient well-written procedures for new processes and equipment or documents showing vital alterations done to suit changing priorities.

Simply, in a cGMP environment, processes cannot remain unchecked with fewer or too many deviations and discrepancies.

“Every morning, I make a round of the facility to check any production or maintenance issues, and if I find any, I make a note of what measures can be taken to lessen the risk of defect costs or reduce the risk of regulatory noncompliance in order to assure the smooth running of the processes,” said Mrs. Afser, who works as a Assistant Manager Quality in a reputed pharma contract manufacturing company.

In fact, to have a high degree of confidence that all batches produced will meet their intended requirements, the responsible team should answer the following:

• Are all the phases and schedules of validation well documented and clarified i.e. pre-validation qualification phase, process validation phase and validation maintenance phase?
• Are respective validation studies conducted in accordance with a comprehensive, pre-established protocol or series of protocols?
• Are the designated persons conducting validation studies suitably qualified and trained and competent to perform the tasks assigned to them?
• Is all data generated during the course of validation studies properly reviewed, analyzed and certified as evaluated to reflect the determined criteria?
• Are appropriate testing facilities, equipment, devices and methodologies available?
• Is there any stipulation set to carry out re-validation of processes at intervals?
• Are all relevant documents complete to classify support and record the overall validation process?

In conclusion, key persons from the respective departments, e.g. projects, engineering and maintenance, production, research and development, quality control and quality assurance must be keenly involved in the diverse phases of multiple validation tasks with the concluding approval given by a validation team.

Image source: pharmamanufacturing.com