GMP Certification - Manual Documents Requirements

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GMP Certification for Pharmaceutical
Manufacturer
Good Manufacturing Practices (GMP) Certification
ensures the integrity of your food manufacturing
process as well as your compliance with food
safety regulations.
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What is GMP?

• 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.
• A GMP is an important enhancement to your food
  safety management system, which increases your
  customers confidence in your commitment to
  trading and producing safe, high quality food.

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Principles of GMP

• The 10 Principles of GMP are
• Design and Construct the facilities and
  equipments properly
• Follow written procedures and Instruction
• Document work
• Validate work
• Monitor facilities and equipment
• Write step by step operating procedures and work
  on instructions
• Design ,develop and demonstrate job competence
• Protect against contamination
• Control components and product related processes
• Conduct planned and periodic audits

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Key Benefits of GMP Certification

• Enhances the food safety management system
• Prove enterprise's management capabilities in
  product quality, safety Assurance
• Enable employees to develop good production /
  operations habits
• Reduce safety risk in product quality and safety
• Timely detect production and management
  problems, reduce cost
• Better understand and comply with the relevant
  laws and regulations.
• Enhance the international credibility and public
  image
• Increase customer's long-term confidence in the
  enterprise
• Helps boost export opportunities.
• Reduced duplication of inspections
• Cost saving

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Documents need for GMP Certification

• The key sections of GMP set out a range of
  documents requirements for minimize the risks
  involved in any pharmaceutical production that
  cannot be eliminated through testing the final
  product.
• GMP Manual
• GMP Procedures
• GMP Process Approach
• Standard Operating Procedures (SOPs)
• Exhibits
• Sample Formats / Templates
• GMP Audit Checklist

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What is GMP Manual?
The GMP manual is a mandatory documents for GMP
certification, guidance for Active Pharmaceutical
Ingredients. This GMP manual included in total
documentation kit for creating Company profile,
Control and distribution, organization structure,
Management Responsibility and more. The GMP
manual shall outline the structure of the
documentation used in the pharmaceutical
companies.
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What is GMP Procedures?
The GMP procedures are designed to help the
organization in developing effective procedures
formed as per GMP requirements, which accelerates
the process of certification.

1. Procedure for management review
2. Procedure for document and data control
3. Procedure for Control of Records
4. Procedure for internal audit
5. Procedure for Training
6. Procedure for corrective and preventive action
7. Procedure for Control of Monitoring and Measuring
   equipments
8. Procedure for Control of NonConforming Products

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What is GMP Process Approach?
It covers guideline for processes, flow chart and
process model useful for process mapping. It
covers process flow chart and activities of all
the main and critical processes with input
-output matrix for organization. It helps any
organization in process mapping as well as
preparing process documents for own organization.
In Input and output matrix list of documents
input and output as well as interlink age of
documents with other departments are given. It
also includes the risk and process wise
opportunities.
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What is GMP SOPs?
All associates have the responsibility to ensure
that all GMP activities are performed according
to the official SOPs, any deviations in procedure
are reported to their supervisor and are
adequately documented.
GMP SOPs should provide specific step-by-step
instructions for performing operational tasks or
activities.
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What is GMP Exhibits?

• The GMP exhibits are very helpful tool to teach
  all employees and staff about how to implements
  and improvements quality requirements for
  pharmaceutical manufacturer and get number of
  benefits.
• Following list of Exhibits covering all the
  details of Good Manufacturing Practice guidance
  for active pharmaceutical ingredients.
• Skill requirements
• Multi Skill requirements
• Control of nonconforming products
• Document codification system
• Quality Plan
• Raw material specification

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What is GMP Sample Formats?
It covers sample copy of blank forms required to
maintain records as well as establish control and
make system. The samples given are as a guide and
not compulsory to follow to change the same to
suit own requirements
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What is GMP Audit Checklist?
The GMP audit checklist is a good tool for the
auditor to make audit question to make effective
GMP internal audit for their organization. It
covers sample audit questions based on all the
good manufacturing practice guidance requirements
based on GMP standard.
It helps the auditor to make own audit checklist
for quick and perfect auditing to ensure all the
good manufacturing practice guidance requirements
are fulfilled.
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