Good Manufacturing Practices (GMP) is the minimum standard that a pharmaceutical manufacturer must meet in their production processes. Process must:
- Be of consistent high quality.
- Be appropriate to their intended use.
- Meet the requirements of the marketing authorization (MA) and product specification.
Pharmaceutical organizations which comply with GMP must have manufacturer license. Regulatory agencies carries out in section on these pharmaceutical organizations to check if manufacturing sites comply with GMP. Sites are inspected when applied for a manufacturer license and then periodically based on risk assessments.
CGMP Legal Principles
Quality built into product
- By "taking care" in making medicine.
- Quality system is based on the principle of Quality by Design instead of quality by Inspection.
- Product(s) adulterated(defects need not be shown).
- Firm and its management are responsible.
- Standards evolve over time.
- Minimal standards.
- Not "best practices". (Unless "best" is, in fact, current minimal.)
Why is GMP so IMPORTANT?
- Is a legal requirement enforced and mandated through law, regulations and directives by each country government.
- To protect public health of each and every individual.
- Prevent contamination and mix-ups.
- Prevents mislabeling and adulteration.
- Consistent maintenance of Quality product supply throughout the product life cycle.
- Ensure high standard quality product supplied into the market is safe and effective.
- Satisfy stakeholders, customers and consumers.
- To meet the requirement of the marketing authorization (MA) and product specification.
- Enhance the organization image and reputation.
Responsibility of GMP
- Quality and GMP compliance are independent of job title and have no boundaries.
- Everyone involves in the process regulatory compliance, manufacturing, packing, Quality Control, distribution and supply of pharmaceuticals product has the responsibility to make sure it reaches to the patient with registered quality standards.
- Building quality into the entire process of an operation makes sustainable compliance more achievable. However, it requires commitment by Senior management and the allocation of adequate resources (personnel, facilities, training, etc.).
