According to the World Health Organization (WHO), GMP or Good Manufacturing Practices or Current Good Manufacturing Practices (cGMP) is a quality assurance mechanism. The WHO released its first draft of GMP in 1968. In the subsequent years, the WHO assembly accepted the WHO GMP as an integral scheme in regulating the quality of pharmaceutical products in the global landscape.

Over the years, more than 100 countries have adopted and implemented WHO GMP provisions into their regulatory laws that govern the pharmaceutical sector. The nations have also modified the GMP requirements to cater to the diverse differences and advocate quality control that brings their products to par with their international peers.

GMP lays down guidelines for production and quality control. The organization has established general measures that ensure that the production process and testing are clearly defined, reviewed, documented, and validated by the concerned authorities. Moreover, it advocates that premises, personnel, and materials used in producing pharmaceuticals and biologicals are suitable for deployment. GMP is backed by legal obligations that cover aspects like testing, responsibilities for distribution, and responses that must address defects and complaints associated with the product.

To obtain GMP Certificate Application and registration, an applicant can apply to either the Joint Commissioner, FDA, or office of GDCI, CDSCO. To receive the certification, submit an application to the concerned authorities along with detailed documentation which must outline in-depth information on the manufacturing process and quality control system. Follow the below-mentioned steps to successfully receive your authorization.

WHO GMP offers numerous benefits for companies, facilities, and organizations that implement its guidelines. These are as follows:

• Adherence to International Standards: GMP Certification for Export verifies that a company follows WHO GMP guidelines and produces safe and high-quality goods. Several countries ask for exporters of other regions to furnish this certificate, and thus these certificates are often termed ‘export certificates’. The certificate ensures that a company follows guidelines specified by international organizations such as the WHO and FDA.
• Cost Reduction: GMP ensures that mistakes do not occur as identifying and correcting it could become a costly affair in the long run. By adhering to the guidelines of WHO GMP, manufacturers can minimize the risks and costs associated with faulty production, drug contamination, and other hazardous risks that arise in production.
• Better Documentation Practices: GMP lays down rules to create detailed documentation and written procedures which is essential to each process. It advocates that there must be a system that provides documented proof ensuring the correct procedure is consistently followed throughout the production and every time when a product is made.
• Process and Product Control: Good Manufacturing Practice (GMP) ensures that products are consistently produced in accordance with quality standards. The approach minimizes the risks involved in production which cannot be eliminated just by testing the end product. GMP norms establish detailed quality criteria for raw materials as well as finished goods; continuously monitoring and improving quality control process throughout the production.
• Compliance with Regulations: Meeting GMP standards helps businesses comply with the legislative orders of national and international bodies. It assists the business in navigating through complex regulatory guidelines and eliminating risks that can lead to the imposition of severe penalties and legal action.
• Enhanced Customer Trust and Confidence: Manufacturers who comply with WHO GMP regulations demonstrate a commitment to maintaining quality through its rigorous production standards. It enhances consumers’ trust and confidence as they believe that the products they have purchased have undergone stringent quality checks and are safe to use.
• Access to Overseas Markets: GMP certification enables businesses to tap larger international markets and export their produce beyond the borders with minimal red tapism. The certification demonstrates that the product is of high quality and safety which helps it gain market access in those countries that mandate GMP for importing pharmaceuticals.
• Decrease in Violations and Complaints: The certification minimizes the risk of contamination in drugs, medicines, vaccines, and other pharmaceutical products. This reduces the likelihood of quality issues and regulatory breaches which can impose severe penalties and tarnish brand image.
• Professional Culture: GMP certification paves the way to professionalism within the organization and emphasizes the significance of safety, quality, efficacy, and continuous improvement.

Several of the countries in the global landscape only accept the import of pharmaceutical shipments if it has been manufactured in compliance with internationally recognized GMP. It has also made GMP mandatory for all the manufacturers of medicine, vaccines, and other pharma products.

The European Union (EU) has implemented a GMP system that is a similar yet modified version of WHO GMP. Similarly, the United States FDA (Food and Drug Administration) has also set in place its own GMP version. The United Kingdom’s 1968 Medicines Act also covers the majority of GMP regulations.

GMP Certification Process categorizes risks involved in production under several heads. However, the major risks are unexpected contamination of products that can cause damage to the safety and health of consumers and death in the worst-case scenario. In addition, incorrect labeling could mean that patients are consuming the wrong medicine and insufficient or excessive active ingredients can result in ineffective treatment or adverse effects.

To tackle these risks, several well-regulated countries such as the EU and the USA follow a risk-based approach to inspection. It is a methodology where manufacturing sites are rated based on the risk they pose to patients, animals, consumers, and users of the medicines.

The CDSCO is responsible for laying down guidelines for cosmetics, drugs, and medical devices and enforcing the GMP rules in the country. It regulates the manufacturers of FPP (Finished Pharmaceuticals Products) and API (Active Pharmaceutical Ingredients). In addition, it includes the following key aspects:

1. GMP specifies details regarding the requirements of sanitation, premises, personnel, documentation and records, storage of raw material, quality control system, self-inspections, site master files, etc.
2. In India, the quality of manufactured drugs is mainly monitored through samples picked up randomly from the market, testing of these products in the designated laboratories, and in case of quality failure, regulatory actions are taken by the authorities by suspension, cancellation, and litigation which depend on the extent of quality failure.
3. The competent authority can also conduct unannounced inspections at the premises of pharmaceutical manufacturers that use active substances.
4. CDSCO employs qualified individuals as GMP inspectors who conduct inspections on manufacturing facilities and verify the safety and quality of produced drugs as per the set standards.
5. Inspections are categorized into two classes: Routine inspection and follow-up inspection. Routine inspections are conducted by CDSCO for the importers of medicines to grant or renew licenses under the CLAA scheme, issue COPPs, approve testing laboratories, and risk-based inspections.

Schedule M (Drugs Rules 1945) prescribes manufacturers to obtain GMP and conform to standards they are mandated to comply with. Compliances to GMP norms are checked through inspections conducted routinely.

1. Risk Based Inspection is an approach that inspects facilities on the basis of inspection history, risk associated with products, and the findings of previous inspections. These measures ensure optimum utilization of resources while ensuring that products meet the specified quality threshold.
2. A risk-based approach enables effective implementation of rules under schedule M and helps maintain a higher degree of patient safety.
3. It makes the best use of resources and surveillance.
4. Such inspections of the pharma manufacturing sites lead to the deployment of a quality risk management system.

GMP Certification Consultants can assist a manufacturer in complying with the set standards and inspections conducted in their building and premises. The officials also inspect areas such as security systems, ancillary areas, disposal of waste, water and compressed air systems, training, health, clothing, and sanitation of workers, raw materials, warehousing area, and equipment. In addition, it also covers manufacturing operations and control, production areas of both sterile and non-sterile preparation, and environmental monitoring.