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WHO-GMP

Our commitment to high quality standards and good manufacturing practices makes it critical for us to ensure that we cover three primary components Process Management, Staff Training & Documentation.

Process Management

VSCL applies Good Manufacturing Practices across all areas of activities including:

• R & D/Process Development
• Manufacturing
• Analytical
• Stability Services

VSCL operates in a culture of continuous improvement supported by internal and external audits. As a result of the crucial nature of stringent manufacturing processes and product quality, our Quality Control (QC) and Quality Assurance (QA) departments closely monitor all GMP activities. All batches are released only after comprehensive testing and approval by QA. This focus on Quality assures VSCL clients of a persistent adherence to GMP specifications and regulatory compliance

Training

VSCL staff receives regular training to ensure that developments and improvements are applied consistently across all aspects of the manufacturing processes. These training and re-training exercises are conducted at regular intervals by the QA team and are not restricted to Our training ensures that our staff remains committed to GMP compliance in the interest of our clients.

Documentation

Effective process management and audit can only be conducted if there is strict adherence to documentation needs to establish a clear trail in case of

• Standards are established for all GMP activities in the form of specifications and protocols.
• All standards are approved by QA and by our customers, if required.
• Master documents, such as master batch records and specifications, are approved and controlled by QA.
• GMP products are released by Quality Assurance; the following certificates are approved and issued by QA:
  • Certificates of Analysis
  • Certificates of GMP compliance
  • Certificates of Origin (confirming compliance with TSE legislation)
• Standard Operating Procedures (SOPs) are available for all GMP activities and are controlled and maintained by QA. These SOPs govern all GMP activities throughout all GMP projects from material management through to packaging and shipping of the product
• All GMP documentation is securely and safely archived for 10 years.