The pharmaceutical industry is oriented to maximum safety and hygiene requirements in all sectors of production, storage and transport. This is particularly true for the intralogistical sequences in the manufacturing process.
Generally speaking, pharmaceutical production can be divided into two sectors: the production of the active ingredients and drugs and the transformation of these drugs into the finished products suitable for use as prescriptions. Active pharmaceutical ingredients (API) can be defined as chemicals that are used for the manufacturing of pharmaceutical agents. Active ingredients (AI) are the substances that are biologically effective in the drugs for the purpose of achieving the desired effect when taken individually.
Conveyor systems have to be matched with hygiene standards
API manufacturers, and bioprocessing plants in particular, are required to recognise binding standards for infrastructure design that permit a more efficient opportunity for cleaning. This ensures not only improved acceptance by quality assurance and by auditing agencies but also state-of-the-art production plants. The Pharmaceutical 3-A Standards (P3- A) provide in this connection the requirements for construction materials and for the design of the equipment to be cleaned that is used for the manufacture of active pharmaceutical ingredients. Similarly, the European Medicines Agency EMA has defined the rules for the Good Manufacturing Practice (GMP) for medicines and active ingredients that are anchored in statutes, regulations and guidelines world-wide. These requirements apply to methods, plants or controls that are used for the manufacturing, processing, packaging and/or storage of medicines (Good Manufacturing Practice for Active Pharmaceutical Ingredients).
In addition, the American Society of Mechanical Engineers (ASME) has released an extensive guideline for the hygienic structuring of production plants in the publication ASME BPE-2009 "Bioprocessing Equipment". This standard is independent and not legally binding.
Pharma Products have to satisfy the local markets
No matter where the API is manufactured, the companies must meet the strict safety and quality requirements of the country in which the products are to be used. Thus, for example, APIs that are produced in China or India for use in the United States must be tested and licensed by the FDA.
Similarly, when utilisation in Europe is planned, then the regulations of the European Medicines Agency must be fulfilled. Regular inspections outside the countries of use can reveal problems with falsified or contaminated substances. It is for this reason that the FDA has steadily increased the number of its employees abroad since 2008 in order to avoid such difficulties. As a result of these measures, countries such as India have in the meantime achieved a fixed position on the global market and have around 75 FDA-certified plants for synthesising APIs.