Poor quality pharmaceuticals and similar medical products pose great risks to patients and healthcare in general. On top of turning into a waste of time, effort and resources, in the end, they cannot deliver the intended treatment results and therapeutic effect. The main reason behind products’ inefficacy and hazardous nature is insufficient or uncontrolled manufacturing environment. In this regard, in order to prevent risks of infections, complications, degradation of medicine, cross-contamination or other negative impact before during and after production, practitioners should strictly follow pre-defined Good Manufacturing Practice (GMP) regulations. Only by complying to these guidelines can researchers, manufacturers and the rest of the personnel involved preserve high quality and guarantee safe consumption of drugs.
In essence, GMP extends to every single moment of drug development, specifies production and control operations and encompasses the use of systems, starting materials, active substances, equipment, sanitation of premises, facilities and production plants. However, in order to ensure 100% effectiveness, the GMP standards and requirements apply to the whole personnel involved in drug development as well. There are dedicated sections which offer useful guidelines and practical strategies for managing complaints, record keeping, documentation, corrective procedures, personal hygiene of staff, as well as their skills, qualifications and even training.
Why are GMP Training Courses Important?
There are various GMP inspections which are carried out by regulatory authorities such as FDA, EMA or MHRA. They have the goal to evaluate the degree of compliance to previously set standards of Good Manufacturing Practices. And because any research company, manufacturing organisation or other institutions in Pharma must be GMP compliant, professionals working in such organisations must be able to provide proof of their eligibility, knowledge and skills in the form of individual or group certificates. If they fail to comply with all of the requirements, they may lose their license or the product may be removed from the market.
Any human subject who is part of manufacturing, packaging, storing, distributing or transporting pharmaceuticals and other medical products must undertake GMP training. Such courses will equip them with enough practical knowledge and industry insight. What is more, it will also help them understand the most crucial aspects of Good Manufacturing Practice such as:
- The use of Pharmaceutical Quality System
- The right approaches to equipment and facilities
- Packaging, labeling and transportation
- Drug Dosage Forms
- Quality Control
- Quality Assurance
- How to manage documentation properly
- oHow to
As a leading training provider, at Astra Nova we have prepared a detailed online course on GMP. It consists of practical examples, video materials, documents and forms, list of GMP regulations, explanations, case studies and more. The training is perfect for QA and QC experts, industry newcomers, engineers, service organisations, suppliers and other people involved in drug manufacturing.
In order to make it even more beneficial for everyone interested in our courses, we are now organizing a Christmas Campaign which offers plenty of individual or corporate discounts. One of the options is benefiting from 10% off the total price for corporate licenses or extending license validity up to 2 years. In terms of our individual training programs, clients can now purchase 2 courses and get a third one for free.
Astra Nova’s Christmas Campaign is running only through December and ends in January, 2017.
You can find a PDF version of this article here: https://crotraining.co.uk/wp-content/uploads/2016/12/Good-Manufacturing-Practice-in-Pharma-Importance-and-Training-Courses.pdf