GMP Compliance

cGMP Training

Our GMP experts can develop a cGMP training program for your plant personnel. These services include the training of operators and maintenance personnel. Our training programs involve the following:
-Programs to ensure validation and cGMP compliance
-Identification of operational hazards by system, subsystems, and equipment
-Identification of training requirements by system and equipment
-Identification of corporate training requirements
-Identification of staffing requirements and personnel level requirements
-Criteria for a training program
Certification of training program. We offer courses in Computer Validation, Cleaning Validation, Process Validation, Preparing for FDA Pre-approval Inspection, Failure Investigation and other topics. Our training targets the personnel who are responsible for implementing and maintaining quality systems. The training is aimed at developing in-house cGMP, compliance and quality standards. We train multi-functional teams including management, production operators, scientists, technicians, R&D, QC & QA, engineers and maintenance personnel.


cGMP Audits

· cGMP Audits
· cGMP Gap analysis Design Reviews
· Software Quality Assurance Audits
· Pre-Approval Inspection Audit Support
· Document Review
· Laboratory audits
· Design and Review of Documentation Systems
· Change Control
· SOPs
· Environmental Monitoring
proGamma’s cGMP Audit process will ensure that your facility meets all applicable regulatory requirements. A proGamma cGMP Audit Coordinator can be assigned to your project so full compliance with cGMPs guidelines is achieved.

 

 

 

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