GMP Compliance Services

GMP regulations mandate a risk-based quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. Key GMP processes include including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Failure of firms to comply with GMP regulations can result in very serious consequences including product recall, plant closure, penalties, fines and severe legal proceedings.

As most GMP requirements are very general and open-ended, manufacturers find it difficult to interpret critical requirements and implement necessary quality and risk controls that assure proper design, monitoring, and control of manufacturing processes and facilities. The Regulatory team at Techsol specializes in providing very focussed cGMP regulatory services that meets the quality criteria mandated by agencies. 

With over 15+ years experience, we carry out various audits including full Site audits which focus on the facility’s quality management systems and cover a large number of products (API and Intermediates) with the following principles:

Pharma Manufacturing | Techsol Life Sciences

How We Can Help

At Techsol, our expert team of Medical writers have an extensive research background, scientific knowledge, and ample experience in contributing to clinical development programs for global pharma companies. 

Following are the key focus areas where our medical writing team has the expertise to deliver high-quality services throughout the drug / device development lifecycle as per applicable regulatory guidelines:

GMP Process Improvement Audits

Clients trust our expertise to complete the following types of audits as part of the cGMP compliance gap assessment exercise. 

QMS Audit: Review GMP compliance and process efficiency

Root Cause Audit: Investigating process failures and associated CAPAs

GAP Audit: Checking GMP Systems, Infrastructure, Resources & Processes

Vendor Audit: Vendor Qualification or Re-qualification Audit

Pre-inspection GAP/Mock Audit: For proactive agency audit preparation 

Sponsored Audits: Audit done on behalf of Sponsor

Process Audit Objectives | Techsol Life Sciences
Data Safety Monitoring Board | Techsol Life Sciences

GMP Training 

We provide in-depth training for manufacturing teams, so you can avoid costly regulatory findings from global agencies. Following are the training focus areas that our team can deliver:

21 CFR cGMP Regulations and associated QMS Processes

SOPs, Checklists and Work Instructions preparation and operating plans

Facility, Equipment, Intrument, Sanitation, Cleaning validation processes 

Access Key cGMP Regulations

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