GMP AUDITING

At SPGL, our team of Good Manufacturing Practice (GMP) specialists is ready to thoroughly assess the systems within your pharmaceutical, biotechnology, or medical device organisation or those of your vendors, to ensure they meet both your production demands and the prevailing regulatory guidelines.

Acting as an integral part of your GMP Auditing team, we are equipped to perform audits for you, employing either your existing audit framework or the SPGL approach, aligning seamlessly with your unique requirements.

Our GMP professionals bring a wealth of auditing experience, conforming to the relevant regulatory and industry benchmarks. Collaborating with you, we apply the appropriate standards tailored to your operation’s specifics, the services rendered, and the current phase of your project. Our evaluations are thorough, pinpointing areas needing enhancement and potential compliance hazards, focusing on systems critical to quality, manufacturing, packaging, labelling, materials management, laboratories, distribution, and the maintenance of equipment and facilities.

Our range of GMP services encompass:

GMP compliance auditing

  • Drug Product (DP) – sterile and non-sterile
  • Drug Product—Sterile Fill/Finish (i.e. Lyophilized, Liquids (i.e.Vials, Cartridges, Pre-filled Syringes, Ampules))
  • Drug Product—Non-sterile Fill/ Finish (i.e. Tablets, Capsules, Creams, Ointments, Oral)
  • Combination Products
  • Medical Device
  • Drug Substance/Active Pharmaceutical Ingredient
  • Laboratory (Analytical and Microbial)
  • Cell-Bank Manufacture and Storage Excipients
  • Packaging and Labelling
  • Warehouse, Storage and Distribution
  • Printed Packaging Components (i.e. Labels, Cartons, Inserts)
  • Components and Consumables (i.e. Bags, Vials, Filters, Stoppers)
  • Sterilisation (i.e. Gamma Irradiation, E-Beam, VHP)
  • Batch Disposition (Qualified Person (QP), Exploitant)
  • Service providers

GMP training/inspection interview training

  • Greeting and reception, answering questions, avoiding opinion and conjecture, preparation of documents and personnel prior to entering the inspection room
  • Gap analysis
  • Interconnection of Quality Systems and compliance with regulatory filings

Facility assessments

  • Utilities, equipment, instrumentation, calibration, preventive maintenance, and on-going monitoring of critical systems
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