Self Inspection Programs Are Important For Detecting System Errors in the Pharmaceutical Industrypharmaceutical industry certainly cannot isolate itself from regional and global developments and competition. The challenges and problems faced by the pharmaceutical industry will become increasingly complex. So that the role of information technology for the pharmaceutical industry is very important and of course it has a variety of objectives, including to support its business interests.
Information systems in the pharmaceutical industry
The information system itself is an arrangement or collection of data, processes, information presentation, and information technology that all interact to develop operations so that they can solve problems and make decisions needed by an organization, management and users. Along with the times and technological advances, all activities related to humans are required to be more innovative and advanced. In this case, the pharmaceutical industry is no exception.
Pharmaceutical Industry is a business entity that has a license from the Minister of Health to carry out activities to manufacture drugs or medicinal substances. In the implementation of making drugs or medicinal ingredients, of course it must be accompanied by supporting technology, starting from the very beginning, namely raw materials and packaging materials until they can be released and get the title of finish good. To say a product has met specifications, it must go through various processes handled by various divisions in the pharmaceutical industry.
Good Manufacturing Practices
Good Manufacturing Practices are guidelines that must be applied in all processes in the pharmaceutical industry in the manufacture of finished drugs. These guidelines aim to ensure that drugs are made consistently, meet the established requirements and are in accordance with their intended use.
This program covers all aspects of production and quality control. In the process of manufacturing drugs, comprehensive control becomes very mandatory to ensure that high quality drugs are not sufficient if the finished product only passes a series of tests, but what is more important is that quality must be built into the product.
The quality of the drug depends on the starting material, packaging material, production process, quality control, building, equipment used, and the personnel involved. Therefore, quality assurance of a drug should be made under controlled conditions and monitored carefully.
Application of Technology in CPOB
CPOB has also described several technologies that can support and be used in the pharmaceutical industry. More precisely in CPOB Annex 1 concerning the manufacture of sterile products which not only discusses the classification and monitoring of clean rooms and clean air facilities but also about isolator technology, blowing / filling / sealing technology, products that undergo final sterilization, aseptic manufacturing and so on. As well as documentation which is an action to provide documents in the form of information and information of accurate knowledge and evidence as a source of special information using technological technology in the pharmaceutical industry.
The use of isolator technology aims to significantly reduce the risk of microbial contamination by humans and the environment to products to be made aseptically.
The isolator and its surroundings should be designed so that the required air quality for the zone can be achieved. Insulators are made of various materials that are resistant to punctures and leaks. Transfers vary from single door, two-door designs to completely closed systems incorporated by sterilization mechanisms.
In general, the area inside the insulator is a local zone for high-risk manipulation, although laminar air flow may not exist in this work area. The air class required for the background environment depends on the design of the insulator and its use. It should be controlled for and for at least Class D aseptic processes.
Isolators can be applied after validation according to procedures including considering critical factors of isolator technology, for example, air quality inside and outside (background) of the insulator, insulator sanitation, transfer process and insulator tightness. In addition, monitoring should be carried out regularly and include frequent leak tests of the insulator and glove / arm system.
The blowing / filling / sealing machine is a series of machines where in a continuous operating system, the product container will be formed from thermoplastic granules, filled and then sealed. All this is done by a single automatic machine unit.
Generally used for aseptic production equipped with an air shower that is of the same effectiveness as Class A and can be installed in a minimum Class C environment, provided that you wear Class A / B work clothes. Machines used for the manufacture of products by final sterilization should be installed in a minimum Class D environment.
The working environment area is expected to meet the requirements for the number of particles and microbes under “non-operational” conditions and the requirements for the number of microbes only during operation.
Some things to consider regarding this particular technology are:
1.Equipment design and qualification,
2. validation and reproducibility of cleaning-on-site and sterilization-on-site,
3.the level of cleanliness of the background environment in which the equipment is placed,
4. training and work wear for operators, as well
5. Intervention of critical machine zone including aseptic assembly process before starting the filling process.
Specifications (starting materials, primary packaging materials, intermediate products, bulk and finished products), master processing procedures and master packaging procedures should be comprehensive in accordance with the latest scientific developments.
These documents should be reviewed periodically during development and updated as needed. Each new version should take into account recent data, the latest technology used, pharmacopoeial regulations and requirements, and should facilitate traceability of previous documents. Any changes should be carried out according to a written procedure, taking into account implications for product quality such as stability and bioequivalence.
SAP (System Analysis And Program)
SAP (System Analysis And Program) is an ERP (Enterprise Resource Planning) software which is currently being applied in several companies in the world. Several countries have implemented SAP in high and middle class pharmaceutical companies or industries in their management processes. From a financial perspective, SAP is known to reach tens of millions.
SAP is considered as a work of technological advances designed and plays a role in facilitating the management process. Another advantage of SAP is the Enterprise software which custom can be designed according to the wishes of the user.