PSPL Pharma

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Manufacturing

It is the culmination of organized efforts designed to ensure that the products meet the required quality for their intended use.

It is Good Manufacturing Practice (GMP) combined with factors such as original product design, evaluation of authorized development work, and review of any abnormal factors identified during and after production.

QUALITY COMMITMENT

Quality is a fundamental principle at PSPL. We adhere to stringent quality control measures across our manufacturing processes, ensuring safety, efficacy, and regulatory compliance for every product.

What do we do

To achieve quality objectives, a robust Quality Assurance System has been established, incorporating Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

  • Conduct vendor evaluations
  • Oversee all quality control standards
  • Perform process evaluations
  • Review current analysis methods to ensure their suitability
  • Collaborate with R&D to define appropriate specifications for raw materials, packaging materials, and finished products
  • Monitor ongoing stability studies
  • Periodically review Manufacturing and Formulation Records (MFR)
  • Ensure compliance with GMP and GLP at all stages
  • Investigate market complaints and product recalls
  • Maintain control samples, working standards, etc.
  • Assist in internal quality audits
  • Conduct periodic self-inspections and audits
  • Coordinate and provide appropriate training for all personnel
  • Review all statutory compliance requirements
  • Master Formula Record (MFR) for each product
  • Batch Manufacturing Record (BMR)
  • Batch Packing Record (BPR)
  • Batch Dockets
  • In-Process Quality Control (IPQC) / Process Control Records
  • Standard Operating Procedures (SOPs)
  • Standard Cleaning Procedures (SCPs)
  • Periodic review of all the above documents
  • Updates in accordance with standard norms

Amwerk is committed to giving back and investing in the community where we live. Our culture of service and teamwork is central to our values, and we support a variety of causes that matter to our employees. Ultimately, our goal is to make a lasting, positive impact on the people around us, including our clients, employees, and the communities we serve.

Amwerk is dedicated to giving back and investing in the community we live in. Our culture of service and teamwork is a key part of our values, and we actively support a variety of causes that are important to our employees. Ultimately, our goal is to create a lasting, positive impact on the people around us, including our clients, employees, and the communities we serve.