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GMP Certification

gmp Certification

GMP Certification Consulting Services India

Introduction to GMP- Good Manufacturing Practice

GMP Certification – Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

 The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.

 

What is GMP -Good Manufacturing Practice

GMP –Good Manufacturing Practice-is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients (Pharma GMP), pharmaceutical products (Pharma GMP) Foods Products (Codex GMP), Cosmetics (Cosmetic GMP) and Herbal Products (Herbal GMP).

Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation.

GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing.

 

Ten Principles of Good Manufacturing Practice   

  • 1.    Design and construct the facilities and equipments properly
  • 2.    Follow written procedures and Instructions
  • 3.    Document work
  • 4.    Validate work
  • 5.    Monitor facilities and equipment
  • 6.    Write step by step  operating procedures and work on instructions
  • 7.    Design ,develop and demonstrate job competence
  • 8.    Protect against contamination
  • 9.    Control components and  product related processes
  • 10.  Conduct planned and periodic audits

 

Why GMP -Good Manufacturing Practice:

  • Ensuring the safety and efficacy of drug products and medical devices.
  • Is a legal regulations, based on the United States Food, Drug and Cosmetic Act.

 

Who should apply

Companies / Person(s) who import or manufacture pharma/cosmetic products, or have products imported or manufactured on their behalf are responsible for applying to the authority to have their products registered

Our GMP Consultants with Pharma, Bulk Drug and Food Industry background will help in application of GMP Principles.

 

What are the benefits GMP brings to business:

  1. Increases the creditability and offers a competitive advantage in the marketplace for contract manufacturers
  2. Increases senior management confidence in the preparedness of manufacturing facilities for inspection;
  3. Decreases the time and cost for companies selecting contract manufacturer.

GMP Certification Consulting approach:

  • Gap Analysis:  Assessment of existing management system practices against the GMP Certification standard requirements.
  • Project Plan: Prepare a GMP Certification implementation project plan based on the time lines looking for; 
  • Orientation Training:  Top/Senior Management orientation on GMP Certification standard requirements and implementation action plans preparation;
  • Developing different levels of documentation ( Tier 1-3/4): Identification of processes required for the products produced and services provided; External and internal issues affecting the business, interested parties needs and expectations, Framing draft quality policy, organizational objectives, role, responsibility and authority, various risks affecting and opportunities arises, functional and system procedures, different implementation formats and checklists;       
  • System Implementation: Implementation of the GMP Certification as per the developed documentation;
  • Company-wide Training: Training on detailed clause wise requirements and relating them to their  departments, 5-S implementation, and Internal audit.
  • Internal Audits: Periodic assessment of system implementation and corrective actions.
  • Pre assessment:  Initial GMP Certification  audit by Certifying agency, and, implementation of corrective actions.

Final Assessment: Certification audit by the Certifying agency and recommendation for certification

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