GMP Compliance Consulting

Our GMP (Good Manufacturing Practices) Consulting Services protect your manufacturing, processing, packing, and holding of pharmaceutical drugs so they meet or exceed regulatory standards.

Medicines have tremendous power to heal, mitigate pain, and prevent disease progression. Medicines also have the potential for catastrophic harm if incorrectly developed, formulated, and used. The FDA has its own principle called Good Manufacturing Practices (GMPs) that dictate the specific responsibilities of a pharmaceutical manufacturing entity. The GMPs are encoded in Title 21 of the Code of Federal Regulations, parts 210 and 211 (21 CFR 210/211 for short).

The GMPs prescribe specific requirements for the manufacturing, processing, packing, and holding of pharmaceutical drugs manufactured for use in the United States. Similar GMP rules apply to other geographic jurisdictions. The specific areas covered by 210/211 include the following:

  • Responsibilities of the Quality Control Unit and Personnel Design
  • Construction and Maintenance of Buildings, Facilities, Ventilation and Sanitation
  • Equipment and Filter Construction, Cleaning, and Maintenance
  • Receipt, (Re)Testing, Rejection, and Control of Drug Components, Containers, and Closures
  • Production and Process Controls, Including Written Procedures, Sampling/Testing, Time Limits, and Microbial Control
  • Packaging/Labeling Control (Issuance, Operations, Inspections, Labeled Expiration Dates and Tamper-Evident Packages for OTCs
  • Holding and Distribution, including Warehousing Operations
  • Laboratory Controls, for QC Testing, Stability Testing, Handing of Reserve Samples, and Laboratory Animals
  • Handling of Returned Product, and Salvaging of Unused Product
  • Records Requirements for Equipment Use/Cleaning Logs, Production (Master) Records, Complaints and for all compliance areas

Pharmaceutical GMPs hold firms accountable for all operations associated with ensuring the safety and effectiveness of a pharmaceutical product as well as ensuring that the product is properly labeled so it is prescribed and used consistent to its therapeutic intent.

Our GMP Consulting & Quality Services review all of the drug standards to make certain your firm is ready for your next audit.

Parts 210 and 211 are U.S. standards, and worldwide standards exist for other jurisdictions. For example, the European Medicines Agency (EMA) regulates pharmaceutical product for the European Union, and the United Kingdom’s regulator is the MHRA (Medicines and Healthcare Products Regulatory Agency). Marketing authorization and compliance standards are not necessarily harmonized across the world, and a regulatory expert is needed to assure compliance for the region where a pharmaceutical product is intended to be sold. This is where our GMP Consultants can help.

Requirements for APIs (Active Pharmaceutical Ingredients) separate from the requirements for finished pharmaceutical products, illustrate the importance of ensuring that the raw pharmaceutically-active substance is manufacturing in a manner that assures appropriate purity and activity once the product is formulated in its dosage form. ICH Q7 is a largely-accepted standard for the GMPs associated with pharmaceutical drugs.