GMP-Good Manufacturing Practice

GMP-Good Manufacturing Practice

About GMP Certification-

Good manufacturing practice (GMP) is a conceptual standard that guarantees products are consistently (quality and all technical specification wise) and continually being manufactured and the various processes are controlled according to proven quality standards requirements. The standard requirements have been designed/developed in a way to proactively control the risks to the end-user from items and products out of production from the company- Food & drugs, Cosmetics, Medical Devices, Pharmaceuticals, etc.

GMP stands for Good Manufacturing Practice regulations developed by the (FDA) Food and Drug Administration under the authority of the FDA- Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and E for drugs and devices.)

GMP standard regulations address issues (internal/external) including documentation, procedures, SOPs, record keeping, personnel qualifications & awareness, sanitation, cleanliness, equipment verification, process validation, and complaint handling; packaging and labeling, etc. Most GMP standard guidelines and CFR requirements are very general, as normally standards are, accepting manufacturers themselves to decide respectively how effectively to interpret and implement the necessary controls. This means that it provides more tractability, but also generically requires that the manufacturer company effectively interpret the guidelines and requirements in an approach that will make sense for each business.

GMP sometimes is referred also being as “cGMP”. The “c” stands for “current,” asking manufacturers that they must employ current and advanced technologies and systems that are up-to-date to comply with the regulation. Systems, Infrastructure, and Equipment are being used to proactively prevent issues, problems, contamination, mix-ups, and non-contaminations and errors, which may have been very good some years ago, but during current/modern times, maybe less than adequate by current standards.

Benefits of GMP Certification-

  1. A Facility / Company / Organization can reap the following benefits, amongst others, from implementing and Certification towards GMP or cGMP: Establishes the fact that the Organization is following to Guidelines set by WHO or FDA and including Local Nationalized standards and Guidelines.
  1. Ensures hygiene and cleanliness requirements throughout the Manufacturing and Logistics Chain.
  1. Good Documentation Practices- documents (eg. Manual, Procedures, SOPs, operational Controls, Risk Assessment, Regulatory Compliances, etc) and Records for evidence.
  1. Design and Operation including management of processes and products related to Medical Devices, IVD products / Items, Medicines/Drugs/pharmaceuticals, active pharmaceutical ingredients, Diagnostics products/items, and Food items.
  1. Establishes the Competence (including Technical) of Personnel.
  1. Establishes the Organization’s system of handling Non-Conformities and Complaints, including proper reporting to Regulatory bodies, wherever required.
  1. Reduction of Costs and best possible Utilization of Resources.
  1. Evidence of Safe and Quality Products and Items.
  1. Compliance with all International and National and Local Regulations.
  1. Builds Customer Assurance and Rapport and Trust.
  1. Entry to International Markets.
  1. Professional Culture within the organization.

    13. Reduction of Complaints, Fines, Product Returns, Re-        processing, Rejections, Non-Conformities, and Claims.

Requirements of GMP Certification

  • Manufacturing facility design, Equipment and Machinery design, procedures & operating principles, and environmental conditions must be controlled.
  • Manufacturing practices and processes including health & safety, maintenance, etc must be clearly defined, validated, and controlled to ensure consistency and compliance with specifications.
  • Operators should be aware and trained and made competent to carry out the production, QA/QC, Logistics, Factory Management, and control of products for the full stages of production.
  • Records should be maintained for manufacture and quality control, and logistics- thereby demonstrating that all the necessary steps required by the defined procedures and instructions.
  • Records should be maintained for 5 to 10 years- based on regulatory requirements.
  • A system must be maintained and established for recalling any batch from
  • Sale or supply.