In every pharmaceutical process, the most feared step is the validation one. This step is critical to ensure the quality and repeatability of the process for the patient, it is also a good indicator for optimization and improvement of the process. The validation can be divided in 4 big parts: Planification and feasibility, Qualification of process and equipment, Process and analytical validation and post validation follow-up.
In the recent years, the adding of requirement by different entities and quality upgrades in the pharmaceutical products leads to an increase of time and effort to secure every part of a validation. The constant changes of equipment, providers, reagent quality, environmental aspects and legal norms involves a new round of validation for already good to go process. A company is always in a edge of an audit that will show gaps and left behind parameters inside a process. The ideal scenario would be to validate every parameter of the whole process from supply chain to final products, this objective is impossible in a reasonable time and competitive environments.
In reality, compromise must be found between external requirements and internal requirements/procedures to obtain a correct view of the process and to be compliant with GMP and national or international authorities. This effort of rationalisation leads to neglected aspect or missed point and inside a validation process, changing scope and objective can be time consuming and leads to fail deadline and deteriorate relation with client.
To avoid these issues for any scale-up or already installed process, a focus on the planification and feasibility must be done to prevent any troubles during the validation process. This part is often overlooked and not done in deep because a time and effort reduction and to accelerate the “go” for production. It is why the project manager must gather a team with all the matters and make a big effort of planification to ensure that all the parts are covered and to make sure that a revalidation must not be needed in the near future. The project manager must anticipate the current and nearly published norms or regulation.
The use of external partner for the planification are very gainful as the external partner as consultant have generally more experience in his last years from different approach and company. The consultant can put his knowledges and skills to look at gaps and missed parts that others company or audits inspections are watchful.
Another missed point from the validation process is a mid-time evaluation, the idea is to re-evaluate the scope and goals established in the planification and feasibility step. The re-evaluation can highlight gaps and provide crucial data and evaluations from the validation of equipment, areas, lab process and other validations parameters evaluated, from these data, the production and QC team can have providential return on experience in the implementation of routine tests and analysis.
