Good Manufacturing Practice Compliance Services in Pharmaceuticals

Good manufacturing practice (GMP) is a process for defining the quality standards which must be met by drug manufacturers. GMP standards define the practices which must be undertaken by the drug manufacturers to ensure compliance to the regulatory environment and the fitment of the drug for the intended use.

GMP lays down written procedures that must be followed at each stage of drug development life cycle. It covers everything from raw materials to equipment used, hygiene standards followed and all the other possible aspects impacting the quality of the product.

Pharma and biotech companies face inspections by regulatory authorities, to establish whether they are GMP-compliant. The failure to follow cGMP (current good manufacturing practice) guidelines can result in the violation of drug safety standards and end up with the product being labeled as adulterated or otherwise unsafe for use.

Inspections to Check for Adherence to GMP Guidelines

Companies which are adhering to pharmaceutical cGMP are subject to inspections from time to time by regulatory bodies, to evaluate whether all the cGMP guidelines laid down for the sector are being met. Inspections are usually conducted with advance notice, although the intimation provided may be very short sometimes.

Inspections evaluate everything from employees to processes used in manufacture, packaging and storage, to identify any deficiencies and ensure that the GMP guidelines are being strictly followed. They also include conducting site visits to all possible facilities such as production facilities, laboratories, storage and transportation areas, etc.

Each inspection is usually followed by formal feedback which provides the observations made during the inspection, allowing companies the chance to rectify shortfalls if any in their compliance to pharmaceutical GMP.

Types of Inspection for GMP Compliance

There are several categories of inspection (which could be proactive or reactive), and these are classified as:

  • Risk-Based Inspections

    These are conducted based on the risk rating of the manufacturer, with the highest rated ones being inspected first. These inspections are usually conducted at a short notice and inspect the manufacturing and distribution facilities.

    A risk rating and feedback is given post the inspection, providing the detailed reasons for this rating. It also spells out the improvements that must be made to make up deficiencies if any which are identified during the inspection.

  • Product-Related Inspections

    These inspections evaluate the compliance to GMP for specific pharmaceutical products.

  • Triggered Inspections

    These are conducted when there is information passed on to inspectors about possible violation of cGMP. The information is usually provided by a whistle blower or a regulatory body.

  • Grading of Inspections

    Inspections identify shortfalls in the system and these shortfalls are classified into three major categories, which are:

  • Critical Deficiency

    A critical deficiency is one which can lead to damaging results such as a seriously harmful side effect in a drug which can put the patient’s health at significant risk. Such deficiencies need to be immediately attended to.

  • Major Deficiency

    A major deficiency is a non-critical one which deviates from compliance with pharmaceutical cGMP guidelines. While they may not bring about any harm to consumers, they are still too significant to be ignored.

  • Other Deficiency

    Deficiencies which are neither critical nor major are classified as “other”, typically as a result of insufficient information pertaining to them.

Actions after the Inspection

The aftermath of an inspection includes a series of corrective actions, depending upon the nature of the deficiencies identified during inspection. A post-inspection evaluation report is sent to the company in question, identifying the shortfalls in the system. This needs to be responded to with details of the corrective action that will be taken, along with a committed time frame within which the corrective action will implemented.

A compliance escalation process is initiated if a pharma manufacturer’s compliance with GMP guidelines is found to be poor. Recommendations are usually given about carrying out improvements that must be made. In the extreme event of critical deficiencies not being resolved, the manufacturing license could be suspended for the company.

GMP compliance services are processes designed to help pharmaceutical companies achieve nearly zero non-compliance, keep up with the industry best practices and ensure top drug quality. Given the health-impacting nature of their products, manufacturers would do well to consider using the services of experienced professionals like RS Calibration.

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