GMP
GMP
EudraLex – Volume 4 – Good Manufacturing Practice (GMP) Guidelines pertain to companies involved in the manufacturing process and quality control of Active Pharmaceutical Ingredients (APIs) as well as finished medicinal products in final packaging. Quoting the above regulatory document:
“Good Manufacturing Practice is that part of Quality Management which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation, Clinical Trial Authorisation or product specification. Good Manufacturing Practice is concerned with both production and quality control.”
Part of the GMP Regulation applies to every entity involved in the manufacturing processes of APIs or medicinal products—primarily the general principles of the Pharmaceutical Quality System. There are also specific provisions tailored to particular manufacturing facilities. Examples include Annex 1 for the manufacture of sterile medicinal products and Annex 2 for the Manufacture of Biological active substances and Medicinal Products for Human Use.
Irrespective of an organization’s size, units holding GMP certification must meet a very extensive list of requirements. Through their implementation and continuous oversight by the supervisory authorities, these companies can participate in the production and quality control of APIs or medicinal products. Some GMP requirements may also be implemented by companies outside the pharmaceutical industry.
Maintaining the Pharmaceutical Quality System itself requires a vast amount of knowledge, resources, and time for continuous improvement. Implementing GMP in a new enterprise or one currently operating under a different quality system poses significant challenges.
Engaging in collaboration with eCValidation for such a project is advisable. Depending on the requirements, scope of services, and business aspects, our support can encompass the following areas:
- Conducting an audit to verify the current area, processes, and documentation for compliance with GMP requirements. This stage involves assessing the client's needs and the scope of the required work.
- Determining the GMP implementation plan, estimating required resources and time, and specifying concrete tasks.
- Developing system documents such as SOPs (Standard Operating Procedures), instructions, SMF(Site Master File), Validation Master Plan(VMP), and others.
- Performing comprehensive risk analysis and criticality assessments.
- Providing GMP training sessions, including general and periodic training, as well as specific process or procedure training.
- Comprehensive qualification and validation execution—including facilities, engineering systems, equipment, computerized systems, IT infrastructure, and processes such as manufacturing, cleaning, transportation, analytical methods, and others.
- Maintaining the GMP system (hypercare)—handling deviations, CAPA (Corrective and Preventive Actions), OOS (Out of Specification), conducting qualification and validation status reviews, etc.
- Preparing and supporting the manufacturer during inspections by supervisory authorities, other supervisory authorities, and client audits.