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cGMP

How does the pharmaceutical industry ensure that drugs are safe, pure and effective?

The FDA mandates current Good Manufacturing Practices (cGMP) be followed that includes  systems established for the design, monitoring and control of manufacturing and testing of the drug. cGMP regulations help to prevent contamination, mix-ups, deviation, or failures that could result in patient misfortune or death. These cGMP systems assures that the drug meets the Safety, Identity, Strength (Bioactivity), Quality and Purity that it purports to possess. MarinBio undertakes the Strength (Bioactivity) testing for drugs from discovery to commercialization.

Although cGMP is essential, it also requires the commitment of organizations such as MarinBio to be dedicated to QUALITY and OPERATIONAL EXCELLENCE. MarinBio successfully passed FDA audits for a commercial drugs, reflective of our commitment to quality and operational excellence.

HOW DID WE DO IT?

Our Quality Management Systems are implement to support the development and manufacture of pharmaceutical drug substances and drug products, including biotechnology and biological products through the product life cycle.

ICH Q10 describes a comprehensive model for an effective pharmaceutical quality system that is based on:

  • ISO Quality Concepts
  • GMP
  • ICH Q8, Pharmaceutical Development
  • ICH Q9, Quality Risk Management

IMPLEMENTATION OF cGMP AT MARINBIO

MarinBio has implemented the framework for providing ALCOA+ Quality Services such as:

Quality Systems Policies (QSP)

Standard Operating Procedures (SOP)

Contemporaneous Documentation for Traceability

Validation of Systems

Facility and Equipment design & maintenance integrating product quality and productivity

Subject Matter Expert training

Supplier Evaluation & Approval to minimize risk

Ensuring Compliance & reviewing complaints

Maintaining data integrity & audit trails

Abiding by the Codes of Federal Regulations (CFRs):

  • 21 CFR Part 11, Electronic Records; Electronic Signatures
  • 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies
  • 21 CFR 210, General information for manufacturing, processing, packing or holding of drugs
  • 21 CFR 211, Finished Pharmaceuticals
  • 21 CFR 820, Quality System Regulation

WHY CHOOSE MARINBIO FOR cGMP SERVICES?

We have over twenty-seven (27) years of experience in helping clients, starting from

  • testing ideas to
  • development and validation to
  • IND/NDA/BLA application to
  • Stability and lot release to
  • Commercialization of drug

The final success of our clients are directly associated with our commitment to Quality,  Operational Excellence, and unparalleled Communication with our clients. Talk with us about how MarinBio can help you through your drug life cycle. We are here to be your scientists and testing partners.