GMP Certification - Documents manual requirements

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.

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.

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Procedure for management review Procedure for document and data control Procedure for Control of Records Procedure for internal audit Procedure for Training Procedure for corrective and preventive action Procedure for Control of Monitoring and Measuring equipments Procedure for Control of Non–Conforming 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-bystep 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.

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Skill requirements Multi Skill requirements Control of non–conforming 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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