Pharmaceutical Manufacturers: 5 Ways to Improve CGMP Compliance

What are CGMPs?

The FDA's Current Good Manufacturing Practice requirements are referred to as CGMP. CGMPs provide procedures to ensure that manufacturing processes and facilities are designed, monitored, and controlled properly. The purpose of CGMP guidelines is to ensure that the food and pharmaceutical products have been tested to fulfill the FDA's minimal requirements for identity, strength, quality, and purity. Developing solid quality management systems, getting adequate quality raw materials, establishing robust operational procedures, identifying and investigating product quality irregularities, and maintaining trustworthy testing facilities are all part of this process.

If properly implemented, this formal system of controls at a pharmaceutical company can help to prevent contamination, mix-ups, deviations, failures, and errors. This ensures that pharmaceutical products are at par in terms of quality standards.

How Does the FDA Oversee CGMP Compliance?

One of the FDA's responsibilities is to maintain uniformity among all pharmaceutical products available on the market. To ensure that pharmaceuticals delivered to the market are of high quality and safe for customers, drug manufacturers must follow CGMP regulations. The FDA fulfills its goals by conducting inspections of both active ingredients and finished goods. The FDA has the authority to visit any pharmaceutical manufacturing facility at any time. Also, industry events or reports of drug contamination may trigger inspections.

Any pharmaceuticals or food products manufactured in the plant are considered adulterated if the FDA conducts an inspection and deems the producer non-compliant. This does not necessarily imply that the drug is defective; rather, it indicates that the drug's production process did not adhere to current Good Manufacturing Practices rules. The FDA sends the manufacturer Form 483, requiring them to respond with a clear explanation and a plan for corrective action.

Learn more about FDA Inspection Essentials here.

Examples of Warning Letters for Violations of CGMP Regulations

Kyowa Hakko Bio Co., Ltd. - 543924 - 08/10/2018 | FDA
OHM Pharma, Inc. - 586428 - 11/19/2019 | FDA
Honest Globe, Inc. - 597177 - 03/15/2021 | FDA
Megafine Pharma (P) Limited - 510862 - 02/24/2017 | FDA

5 Ways to CGMP Compliance

Both raw materials and finished products must undergo laboratory testing as part of the manufacturing process, according to the cGMPs. To achieve this goal, whether it's for raw materials, equipment, reagents, or other ingredients, all suppliers must meet the manufacturer's criteria. To ensure the accuracy of Certificates of Analysis (CoA), manufacturers must define parameters for supplier certification and conduct supplier audits.

The most common error is a mismatch in labeling. According to independent tests, the product's real ingredients may differ from those indicated on the label. The manufacturer failed to properly examine the source material or clearly specify the content of the finished product. Each raw material and the finished product should have precise specifications. A certificate of analysis (CoA) for each raw material should include a description of the appropriate identification test techniques, as well as the test's restrictions and results.

Whether laboratory services are in-house or delivered by a contract analytical facility, the facilities must be sufficient to conduct the required tests and examinations. The laboratory's comprehensive records must be available during audits. In-house testing methods can be put through a formal validation process to show that they can consistently deliver accurate results.

Inadequate Master and Batch records are the second most prevalent fault that disqualifies manufactures from GMP compliance. The Master Manufacturing Record (MMR) is a comprehensive set of instructions for creating and testing a product. Each product's Master records must be accompanied by a Batch record that conforms to the information on the Master record for each batch manufactured. The Batch record provides the essential paperwork to show that each step in the MMR was completed and that the resulting product met pre-defined requirements to comply with GMP standards. Before the product is discharged from the manufacturing unit, quality control personnel must verify each step. Written records should be kept and stored for a predetermined amount of time. Records should be kept electronically in accordance with 21CFR11.

Quality control is an important part of GMPs. Audits, however frequently find this area to be lacking. The QC team is responsible for ensuring that the production, packaging, labeling, and storage facilities all follow CGMP guidelines.

Laboratory testing methods that do not use scientifically valid analytical methods or follow established procedures are examples of problem areas. Requirements for all materials should be defined, and the procedures used to develop those specifications should be available at audits, according to the CGMPs.

To fulfill their duties properly, each member of staff must have the relevant credentials and/or experience. Personnel should be instructed to follow established standard operating procedures when performing manufacturing tasks (SOPs). When processes change, SOPs should be updated, and individuals should be trained and overseen for their respective jobs. Processes for conducting a material review and making a disposition decision, as well as procedures for approving or rejecting any reprocessing, must all be followed to the letter in the QC operation. Any violations of the SOPs, as well as the steps taken to address them, should be documented. SOP compliance should be documented on checklists or forms and evaluated regularly.

Quality Assurance (QA) is a management function that checks and assesses many aspects of a manufacturing facility and its processes regularly. The Quality Assurance (QA) section works independently to audit all functions, keep proper records, and train employees. When flaws are discovered, the QA staff should determine the necessary corrective and preventive actions. The purpose is to improve quality standards and ensure that a product meets defined identification, purity, strength, and composition requirements.

To stay on Top of CGMP Compliance, attend the Annual Current Good Manufacturing Practices (cGMP) Training. This training provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in CGMP. This session will focus on the FDC Act and 21 CFR federal regulations as applied to CGMP.