Knowhow-Now Article

Most of the renowned players in pharmaceutical manufacturing industry outsource manufacturing and at the same time quality is ensured. There are numbers of factors that are behind such steps, but now it considered as a necessity for all big players due to excessive work load. Such activities have raised the need of training in the field of quality agreement. There are only few people who are actually aware of quality agreement with limited experience. It not only covers the implied meaning of agreement on quality but also addresses the technical and critical part.

Simply quality is defined as a degree of standard or excellence. It has been constantly sought by pharmaceutical contract manufacturing organizations. GMP infrastructure, GMP audit and GMP compliance are well known in the industry. Organizations hardly realize that they have the duties while contracting with pharmaceutical contract manufacturing organizations. The registration process gets easier once the details of processes and procedures in document are ensured carefully. Negligence is mainly due to lack of awareness and trainings in this domain. Thus it is mandatory to have a proper pharmaceutical training.

It is generally expected from the participants in the training that they would be able to abandon a myopic vision for quality and also have a focus on neglected areas. Many are well aware of supplier details for raw materials and check the expiry details and conditions, but reference samples and compatibilities are seldom taken into consideration. Similarly, in the process of production, it is important to have in-process controls and samplings. Specifications should be agreed upon in advance for the final product and should be subjected to pharmaceutical analysis against GMP validations and standards.

Quality-related issues are cleared at the time of training only. Stability study designs, sampling at various stages, labeling and packaging specification, bulk approvals, batch number details, and other such information should be given meticulous attention. It is observed that documentation and archiving is something that is mostly neglected. Therefore it is important to teach and preach documentation and archiving.

We all know that change is the only law of nature but it is hardly welcomed. There are only few people who are actually prepared for the challenge. One need more pharmaceutical training on change control rather than on pharmaceutical regulatory specifications. It would help in defining the level for quality and learning the acceptance deviations in quality and quantity.

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