Posted by: GxP Cellators on November 17, 2021
Designing a robust Quality Management System(QMS) is always a challenging task for the new Pharmaceutical and Biopharmaceutical companies. A robust QMS helps perform the routine operations smoothly and maintain the highest compliance as per the regulatory needs. QMS-controlled documents have been found to be of immense use in proper working, training of personnel and favourable outcomes in the Pharmaceutical and Biopharmaceutical industries. Therefore these documents are an essential part of evaluating the quality of the manufactured products and defining the company’s culture. QMS-controlled documents are a written set of instructions that an end-user should follow to complete a job safely, with no adverse effect on personal health or environment and maximizing the probability of a beneficial health outcome efficiently.
QMS practices are applicable from the earlier product development, non-clinical, and earlier clinical to later clinical operations. However, different stages of the product development have different requirements for the Quality Management System requirements.
At GxP Cellators, we help our clients design a robust QMS for the non-clinical and earlier clinical to later clinical stages. Our technical writers are highly skilled in designing the documentation for GCP, GLP, and GMP operations as per International Standards Organization (9001, 17025, 13485), Health Canada, U.S. Food and Drug Administration and European Medicines Agency.
We are expertized in designing the documentation for site qualification & commissioning, instrumentation qualifications, process validations, cleaning & method validations, computer system validations, vendor management & qualifications, regulatory dossiers, stability program & protocols designing, stability data request forms, and audit response to the regulatory observations.
So far, we have completed multiple projects serving our clients by setting up the robust QMS as per the various regulatory expectations. Our designed QMSs are evaluated by the different regulatory auditors and sponsors/clients from across the globe, with no critical observations found.