+390677209020 | +39 0267380552 info@direnzo.biz | sedemilano@direnzo.biz

Lingua

GMP, safety and quality in all manufacturing sectors

The manufacturing of all those product coming into contact, either directly or indirectly, with humans can affect their health, and for this world legislation has always taken care of ensuring the issue of laws, regulations and guidelines for all manufacturers, not only of medicinal products but also of medical devices, cosmetics, food supplements and PMCs (presidi medico chirurgici, medical surgical aids).

Pharmaceutical GMPs

In general, all manufacturing companies are bound to make excellent products, in order to ensure high quality and safety features of the finished product. In the pharmaceutical field, the Good Manufacturing Practice (GMP) is a tool created to induce and support companies to the accomplishment of this purpose.

The GMP originates from regulating documents issued by the Code of Federal Regulations (CFR), the regulating code issued by the Executive and by the Federal Agencies of the Unites States of America and published in the Federal Register, the equivalent of the Official Journal of the Italian Republic, and were adopted in Europe through the Directives 2001/83/EC and 2001/94/EC.

The GMP is used to protect consumers from purchasing a non effective or even hazardous product, and to ensure the product quality, just for the purpose of minimising every risk, as well as to ensure product uniformity.

The GMP is made of a series of chapters, divided based on general topics (e.g.:  ManufacturingQuality control etc.), as well as by technical and specific annexes addressing in details some aspects of pharmaceutical quality; it is a set of rules describing the methods, equipment, means and management of manufacturing to ensure appropriate quality standards, and that companies should follow to minimise risks and that can arise upon production.

The mechanism of finished product sampling can only provide statistic assurance regarding the fact that the samples (and the areas near the place where the samples are withdrawn) are suitable for use; consequently, as final controls are all based on sampling techniques, the GMP imposes controls before every process related to manufacturing, hence a quality management system carried out via manuals, procedures and above all, documental records.

GMP guidelines

The GMP guidelines are not providing instructions on how products should be manufactured.   Actually, they are a set of general principles to be met during the manufacturing process. When a company develops its own manufacturing process and its quality program, there can be different ways to meet the GMP requirements.  The company itself is responsible for the determination of the most effective and efficient quality process.

In any case, however, the essential rules for the GMP are the following:

  • document, through specific records, every aspect of the process, every activity and operation;
  • use staff who received specific training;
  • take care actively of the cleaning and sanitisation of the facilities;
  • carry out periodic in-house audits;
  • control environmental conditions;
  • define and control manufacturing processes. All critical processes should be validated to ensure the consistency and compliance with the specifications.  Any change in the processes affecting the product quality should be validated;
  • verify periodically that tools and machinery is working properly;
  • avoid any contamination of the product with hazardous materials;
  • perform the traceability and tracking of the product and starting materials, as well manage any withdrawal of the product from the market;
  • manage non conformities and complaints.

European food standards

The essential European regulations, as far as food regulation is concerned, have seen several adoptions, abrogations and amendments since 1962.

Regulation EC n. 178/2002 lays down the general principles and requirements of food legislation, institutes the European Food Safety Authority (EFSA), fixes some procedures in the field of food safety and is the core from which a whole “package” of community regulations was generated (Hygiene Package).

The regulation in force applies to all food business operators (FBOs) operating in the different steps of the chain such as processing, manufacturing, handling including retail sale and distribution, and appoints them as main responsible figures for the food safety, specifying that the general reception of the procedures should be based on HACCP (Hazard analysis and critical control points) principles. The regulations also provide for the drafting of appropriate hygienic practice manuals  dedicated to processes supporting companies in the compliance with the rules.

Any processing of food products, or of any company using them, should develop a HACCP system and adjust it to the conditions of the single product. The “quality assurance system” complying with HACCP should have a structure that is suitable for the company’s activity and size, and is also implemented providing pre-set instructions and consequential procedures to be applied, training the company’s staff, preliminarily selecting the material used, i.e. qualifying the suppliers and controlling the in-coming goods. As for all quality systems, also HACCP provides for that all documents regarding the manufacturing process and all manufacturing steps are stored.

Production of medical devices

For the manufacturing of  medical devices, most world’s companies use the ISO 13485 standard. In the US, the FDA requires a GMP quality system also for medical devices – this is defined in 21 CFR Part 820.

The ISO 13485 standard is an independent standard, derived from the ISO 9000 series, and suitable to the field of medical devices.

The ISO 13485 is also based on the concept of the ISO 9000 cycle Plan, Do, Check, Act, and was designed in compliance with the existing regulations.  It includes no strict rules regarding the environments and manufacturing  process but it indicates the general lines to maintain an appropriate and effective quality system.

GMP in cosmetics

As for cosmetic manufacturing , in 2009 Regulation 1223/2009 was published, with the purpose of simplifying procedures and promote control in the market to ensure a high level of protection for human health.  In order to ensure the product safety and better protect consumer’s health, among other things, the regulation has provided for that manufacturing and packaging activities of cosmetic products are carried out in compliance with the good manufacturing practice.

The harmonised rule describing the specific GMP requirements for the cosmetic sector is UNI EN ISO 22716: 2008 “Cosmetic products – Good Manufacturing Practice  (GMP) – Guidelines on  Good Manufacturing Practice”. This document, specifically dedicated to cosmetic industry, provides for the guidelines for the manufacturing, control, storage and shipment of cosmetic products.

As for all GMP and ISOs, it provides for that any manufacturing site has a quality management system, with similar principles to those listed in rules/guidelines for the manufacturing of other goods categories previously treated.

Written by: Michela Tonci

Foto di aymane jdidi da Pixabay