What is GLP?
GMP stands for Good Manufacturing Practice, & the term is used globally for managing the control and management of manufacturing, testing, and overall quality of pharmaceutical products. It defines certain guidelines that talk about the quality assurance approach. GMP certification ensures that products are produced following the quality standard norms. Joint Commissioner is authorized by Commissioner, Food & Drug Administration, to sign & issue the certificates under the WHO-GMP certification scheme. GMP certification deals with issues like documentation, record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, sanitation, complaint handling, and process validation. GMP requirements are not peculiar in any sense instead they are open-ended and easy to implement also these requirements give liberty to the manufacturer to decide individually how to efficiently implement the necessary controls.
Benefits of GLP Certification
Increased confidence in the reliability and trustworthiness of laboratory data
Increased production of right first time results.
Increased overall productivity.
Increased laboratory reputation.
Reduced need for re-work
Reduced time spent on non-revenue earning investigations.
Check out the Who can be certified GLP Certification Video
Who can be certified GLP Certification?
Food & Beverages Labs
Food Packaging Labs
Colour Additives Labs
Animal Food Additives Labs
Non-Pharmaceutical Products Labs
Ingredients Labs
Biological Products Labs
Electronic Products Labs
Document required for GLP Certification
- System Manual
- System Procedure
- Policy
- Objectives
- Mission & Vision
- Standard Operating Procedure (SOP)
- Checklist
- Forms
- Formats
- Records
The extent of Documented Information differs as per:
- Organization’s size
- Activities performed by the organization
- Processes undertaken by the Organization
- Products and services offered by the organization
- The complexity of processes undertaken
- Competence of persons involved
Role of Shamkris and Process of GMP Certification
Shamkris adopts a results-oriented approach to effective system implementation in the organization. A simple and practical method of system implementation helps organizations increase business efficiency and sustainability. Shamkris supports 100% documentation to obtain an accreditation body of success in addition to enhanced performance.
The implementation process is described below:
Day 1
GAP Analysis, Certification Body, Selection, Cost Estimates
• Finding the GAP between existing system related to GMP requirements
• Selecting the appropriate certification Body
• Based on the scope of your business & certification Body you choose
Week 1
Developing Documents
• Management System Manual, Management System Procedures, Policy, Objectives, Forms etc.
• Review of Standard Operating Procedures (SOP)
Week 4
Implementing Management System
• GMP Awareness training for the top management and staff
• Implementing a well-documented management system throughout the organization
Week 8
Internal Audit
MRM
CAPA
• Internal audits identifying nonconformities related to GMP requirements
• Management Review Meetings
• Corrective and Preventive Action plan for nonconformities
Week 10
Certification Body
Audit
N-C Closing
• Shamkris acts on your behalf and assists you in the third-party audit
• Closing of any nonconformities identified by the certification body
Week 12
Certification Body
• GMP certificates issued for 1 years
Year on Year
Yearly Compliance
• Support of Yearly documentation for audit
FAQ
Good laboratory practice or GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies.
Compliance with the OECD GLP principles helps ensure that non-clinical studies follow internationally accepted requirements.
GLP helps to ensure the credibility and traceability of data submitted, thereby addressing the issue of non-reproducibility in many biopharmaceutical experiments. GLP is intended to minimise adverse drug effects and improve human health and environmental safety profiles.