Compliance with GMP is mandatory for all medicinal products to receive the manufacturing authorization.
Why do we need Good Manufacturing Practice (GMP) ?
- Pharmaceutical products are subject to high quality standards as part of submission for regulatory approval. Among these are: reporting adverse drug reactions; monitoring clinical trials and conducting inspections of manufacturers; compliance with good clinical practice (GCP); good manufacturing practice (GMP); good distribution practice (GDP), and good pharmacovigilance practice (GVP).
What is the Manufacturing Authorization?
- For their manufacture, distribution and marketing authorization, a manufacturing license is required. Therefore, for a drug manufacturer, the manufacturing authorization is an essential GMP property.
About Qualification and Validation
- Qualification and validation are key GMP requirements for the implementation of those quality standards. Validation operations, especially in producing sterile biopharmaceuticals, can be very challenging. The procedures are arduous and requires conscientiousness and commitment, knowledge and experience, as there are predetermined specifications and regulations to meet.
What makes biologicals unique and different?
Proteins can be 100 to 1000 times larger than chemically synthetized small molecules. Due to their large size and complex structure, biopharmaceutical production entails complex manufacturing processes. They are highly sensitive to modification during and after production.
The manufacturing process can affect many parameters, including amino-acid structure, side chains, post-translational processing and tertiary and quaternary structure. Changes could have a profound effect on protein function.
Therefore, biopharmaceuticals are different from synthetic small molecules in terms of molecular size, three-dimensional shape, and process specific impurities. The formulation of the final product is distinct in terms of excipients, bioactivity and stability.
Inconsistencies during manufacturing can lead to inter-batch variations and inconsistency of efficacy. Regarding the manufacture of biopharmaceuticals, the control of quality, safety and efficacy especially in terms of “batch-to-batch” consistency is more complex and demanding.
The responsibility of the regulatory authorities, as part of their review, is to inspect the manufacturing process and the manufacturer’s control strategy for these product variations.
Establish Product Regulations
Product Safety
- Microbial agents
- Tumorgenicity
- Pyrogenicity
Product Characterization
- Identity
- Purity
- Impurities
- Potency
- Quantity
Manufacturing
- Process Control
- Validation Program
- Qualification Program
- Quality Control Tracking
- Quality Assurance Tracking
