Pharmaceutical Documentation, Pharmaceutical Qualification Services

Significance of pharmaceutical documentation

Documentation is essential since it is important to capture information precisely in the medical device and pharmaceutical industry. Although products and documents are produced in pharmaceuticals, regulatory bodies want to view documents first.

Proper documentation happens to be a systematic process of preparing, verifying, storing, issuing, and reviewing any documents. One can define a document as written proof or statement of activities in pharmaceuticals. We require documentation for defining the manufacturer’s system of control and information, reducing the threat of misinterpretation, providing unambiguous processes to be followed, allowing calculations to be verified, and enabling monitoring of batch history.

Purposes of documentations

It is imperative for documentation to be readily retrievable for satisfying the requirements related to product investigations, formal outlets, or periodic product reviews.

It is imperative for all bioscience, pharmaceutical, as well as healthcare companies along with their vendor partners, to observe face warnings levied by the FDA.

On most occasions, the implications of not sticking to GDP are severe and is possible for companies to face serious troubles for not sticking to the proper guidelines or policies.

Our company has a reputation for providing these types of pharmaceutical documentation services at present.

Pharmaceutical process validation services

By the term process validation, we refer to a stepwise procedure to make sure that it is possible for a manufacturing process to produce quality items consistently. A validation team will perform this process controlled by the quality assurance head of manufacturers. In general, process validation will be performed before the release of a new item, or verifying the process at regular intervals, and when implementing any modification on any existing product. It is imperative for a protocol to verify the steps of the execution of the validation process such as the parameters that have to be monitored, the outcomes to be accepted, and the samples to be taken.

Process validation stages

Process design

During this stage, the process of manufacturing will be defined in such a manner that it will be able to reproduce the delivery of any medicinal item satisfying pre-determined specifications. The validation team of our company has a vast knowledge of the functioning of this process.

Process qualification

This particular stage entails the evaluation of process design for figuring out whether it is effective for a top-quality production. Initially, it is imperative to design the manufacturing facility as per the specifications of CGMP. Next, it is imperative to conduct the qualification of equipment and utilities to make certain that they are manufactured and installed compliant with the design specifications. Lastly, it is essential to execute a process performance qualification by a protocol.

Continued process verification

This stage deals with the setting up of systems to continually make sure that the validated procedure remains in such a manner at the time of routine production.

Process validation types

Prospective validation

Prospective validation will be implemented when the product is manufactured within a new facility or with the help of a new formula.

Retrospective validation

Retrospective validation is executed when the process of manufacturing has not gone to any documented validation formally.

Concurrent validation

Concurrent validation is performed at the time of regular pharmaceutical production for showcasing that the procedure functions at the desired level in its actual execution course.

Revalidation

This type of process validation is primarily utilized for medical devices compared to drug products.

Pharmaceutical qualification services

The process of production of items in the present pharmaceutical industry has to undergo various stringent regulations and they must comply with European and FDA standards. In case a plant subject is operated for validation, it’ll be imperative for you to provide evidence that the entire pharmaceutical process control system fulfills the specification.

Our company is fully prepared for these types of pharmaceutical specifications and will help you gladly during all the qualification procedures:

The entire process of planning will be enumerated in the design specifications. At this particular stage, we help to make sure that your requirements are satisfied fully and that every overriding regulation and directive is being complied with.

Pharmaceutical MEP contractor services

We will take care of all your MEP requirements thanks to our vast in-house experience. We will provide different types of services as well as utilities such as compressed air, boiler steam, cooling water, vacuum, nitrogen, raw water, oxygen, chilled water, ahu condensate, LPG, etc. The same will be applicable to electrical installations as well. There is hardly any doubt that we will do all these with the best possible finish.