Conformity guidelines for the right practices
GMPs provide for framework that guarantee proper design, monitoring, and control of manufacturing processes and facilities, thereby assuring the quality, identity, strength and purity of the drug manufactured in the facility. The GMP requirements are flexible and vary from country to country to allow each manufacturer to decide individually how to best implement the necessary controls. Therefore, it is crucial to have a wholly trained expert, by your side to implement these guidelines, while designing your facility.
In pharmaceuticals, less expensive is more expensive. Making poor quality products does not save money. GMP is designed to ensure that mistakes do not occur. Implementation of GMP is an investment in good quality medicines. This will improve the health of the individual patient and the community, as well as benefiting the pharmaceutical industry and health professionals.
Additionally, most countries will only accept import and sale of medicines that have been manufactured to internationally recognized GMP. Governments seeking to promote their countries' export of pharmaceuticals can do so by making GMP mandatory for all pharmaceutical production and by training their inspectors in GMP requirements.
Having spent several years in the pharmaceutical industry, with our focus being compliance to various guidelines, Pharma Access has GMP compliance solutions while designing your facility. With our professional team on board, we have the expertise and international; exposure to handle varied demands related to GMP in the following ways:
At Pharma Access, Quality takes the centerstage in all our discussions. Right from conceptual stage till the manufacture of investigational medicinal products and furthermore to technology transfer, commercial manufacturing through to product discontinuation, the quality cycle never stops and thus this is ingrained in our philosophy right from initiation of the project.
Our trained personnel with vast experience in executing various GMP compliant facilities are a right blend of people equipped enough to carry out the production and control of products according to documented and approved procedures.
The facilities designed by Pharma Access are located, designed, constructed, adapted and maintained to suit the operations to be carried out. The facility and equipment layout are designed with an aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt and, in general, any adverse effect on the quality of products.
Good documentation practice is the one which stores the right set of data which can be referred to any time for analyses, improvement, adaptation and correction in the ongoing practices. As such, it is of paramount importance. Some of the documentations required as per GMP are SOPs, Specifications documents, Site Master file, Electronic batch recording data, certificates, approvals, Manufacturing records, packaging records etc. As such, Pharma Access while supplying machines and equipment ensures it follows good documentation practices.
We engineer the facilities in such a way that the manufacturing processes are clearly defined, validated and controlled to ensure consistency and compliance with specifications. Any changes to the process are evaluated from a patient safety and product quality perspective, and any approved change that may affect the quality of the drug are qualified or validated as necessary.
Quality Control is concerned with sampling, specifications and testing as well as the organization, documentation and release procedures which ensure that the necessary and relevant tests are carried out, and that materials are not released for use, nor products released for sale or supply, until their quality has been judged satisfactory.
The right Corrective and preventive actions (CAPA) is always to be put in place to address the complaints and product failure during the product life cycle. This leads to the drawing board for the necessary root-cause analysis and check the chain of events that led to the failure of products. As such, recording at every level becomes paramount.
A dedicated inspection officer for regular inspection of the facility to ensure set processes are always being adopted and followed. Self-corrective measures are faster and leads to better results. Internal and external audit teams may be appointed for such inspections with qualified personnel keeping track of all near miss incidents to ensure quality assurance. Likewise, we at Pharma Access ensures every project passes the right quality check and feedback mechanism at all intervals ensures a better product (read Project) is delivered every time.
Even the activities that are outsourced are to be done with GMP perspective. Hence, qualified personnel with right tools and techniques is to be hired for outsourced activities of the pharmaceutical facility.