How do you compare GMP to ISO, ICH, and FDA quality standards?

GMP is a set of quality standards and guidelines that are used in the pharmaceutical industry to ensure that drugs are produced consistently and meet quality standards. GMP is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. GMP guidelines cover a wide range of topics, including facilities, equipment, materials, personnel, documentation, quality control, production, packaging, labeling, and storage. GMP guidelines are designed to ensure that every aspect of the manufacturing process is controlled and documented, and that products are produced consistently and to the required quality standards.

GMP is a framework of basic compliance standards to consistently produce safe and effective products. It is designed to prevent further risks that cannot be eliminated through quality control at each step of the manufacturing process.

GMP vs ISO: In the United States, it is legally required to comply with Current GMPs. There are no legal requirements in the United States for any company to be specifically compliant to the ISO 9001 standard. ISO 9001 requires that a management representative oversee the QMS. It doesn’t specify a quality control unit, as do the GMPs. ISO companies would benefit from the GMPs’ systems control and documentation requirements, and the product would benefit from the GMPs’ standards to demonstrate “safety, strength, quality, and purity” of the final drug product. ICH vs FDA: The FDA regulations require records be adequate and accurate, however ICH GCP guidelines are more detailed, require records be ALCOAC.

These cGMP are designed to help organizations assure drug products are the correct identity, strength, purity, and quality. If cGMP is followed, organizations can avoid many of the most common causes of quality failure which threaten patient safety, such as drug contamination, deviations, or mix-ups.

And ISO 9001 for Quality Management System that contributes in maintaining the quality and efficacy of the pharmaceutical products until it reach to the patient.

The ICH is intended to provide guidance regarding (GMP) for the manufacturing of Active Pharmaceutical Ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess. This Guideline applies to the manufacture of APIs for use in human drug (medicinal) products. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile. The sterilization and aseptic processing of sterile APIs are not covered by this guidance, but should be performed in accordance with GMP guidelines for drug (medicinal) products as defined by local authorities.

This also goes for other major markets, such as the European Union (EMA), UK (MHRA), Japan (MHLW) - who all have their own requirements. All require compliance to GMP, although specific details may vary.

Whenever ISO, ICH, and FDA updates their standards; industry is required to update their GMP practices in order to meet regulation or the requirement set by them.

GMP, ISO, ICH and FDA quality standards have some similarities, they also have some important differences. Each of these standards is focused on ensuring quality in the pharmaceutical industry, but they provide different types of guidance and requirements, and are enforced by different entities. Companies in the pharmaceutical industry must comply with all relevant standards and regulations to ensure that their products are safe and effective.

Compliance with GMP and FDA standards is not only about bringing "advantages to your organisation". Compliance is mandatory and provides you with your license to operate. Without licenses, you don't have a business. It should be noted that compliance with FDA will meet US requirements, but not necessarily those of other markets. These will have their own set of requirements - many of which will be common, but may also be specific to that market.

The FDA published a proposed regulation, requesting public comment, to amend the device current good manufacturing practice requirements of the Quality System (QS) regulation (21 CFR Part 820) to incorporate the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes. The FDA seeks to harmonize its requirements for a Quality Management System (QMS) with internationally recognized regulatory requirements for Quality Management System (QMS) for devices, ISO 13485, which is used by many other regulatory authorities.