GAP Analysis

GAP Analysis in Pharmaceuticals

GAP Analysis in Pharmaceuticals | GAP Analysis and Facility Assessment

Knors Pharma one of the leading pharmaceutical GMP audit consulting firm in India. The company is involved in providing auditing services such as GAP analysis in pharmaceuticals, GAP assessment in the pharmaceutical industry, GAP analysis and facility assessment, and GAP assessment in pharma industry, etc. GAP analysis is a way to compare current conditions and practices in order to identify gaps and areas in need of improvement with regards to compliance with the relevant standards, defined by Health Authorities (HAs). Gap analysis/Regulatory Assessment is used by all the pharmaceutical companies to analyze processes of any division of their company. In this process, we follow all the guidelines of all current practices and make a review for adequacy, suitability, effectiveness, compliance. Here at Knors Pharma help to the pharma industries to identify all the Gaps and also help to find which process need to be fixed like quality management process, internal communications process, document control process, record keeping process, training process, internal audit process, management review process, measuring and monitoring process, monconformance management process, and continual improvement process.
In this way, an intensive gap analysis/specialized evaluation of the documents/data/information empowers the pharma manufacturers to distinguish and moderate the gaps before regulatory accommodation. It will keep away from Regulatory dismissals of the entries and limit the major/basic inquiries to attach the endorsements. Gap analysis of the legacy dossiers against current practices followed in the manufacture of the medicinal products.

  1. US 21 CFR 210-211 (cGMP), EU GMP part I and EU GDP for Medicinal products
  2. ISO 13485, US 21CFR 820, EU GMP Part 1 with Annex 10 for Sterile Medical Devices and Medical implantable devices
  3. EU GMP part II for API (ICH Q7) , EU GDP for API, US 21 CFR 210-211 (cGMP) for Active Pharmaceutical Ingredients, Pharmaceutical Intermediates, Pharmaceutical Raw Materials
  4. ISO 22716 for Cosmetic Ingredients
  5. ISO 15378, PS 9000 For Primary packaging for medicinal products
  6. ExciPAct, EU IPEC GMP, EU IPEC GDP for Pharmaceutical Excipients

Knors Pharma Solution auditors have cumulative auditing experience of more than 300 audits. Audit reports of our auditors are accepted across the globe and reviewed during regulatory inspections.