At Astrea Bioseparations we put product quality first and have committed to become the first chromatography adsorbent manufacturer to achieve full GMP compliance!
We pride ourselves on the quality of our products and continually aim to develop and improve our Quality Management System (QMS). In 2016 the decision was made to develop the company’s QMS to a level equivalent with cGMP for Active Substances used as Starting Materials. Although chromatography adsorbent manufacturers are not required to manufacture their bioseparation products in a GMP facility, we have taken the initiative and developed a QMS compliant with Part II of the Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017 by the MHRA (Orange Guide). In addition, all of Astrea’s chromatography adsorbents are manufactured in controlled-access clean-rooms certified to ISO 8 standard or better which provides additional quality assurance for our products.
By July 2017 we had upgraded our ISO 9001:2008 accreditation to the ISO 9001:2015 standard and introduced an updated Quality Manual in line with the basic requirements of Part II of the Orange Guide. As such we now comply with the International Council of Harmonization Guideline Q10 on Pharmaceutical Quality Systems.
Recent developments since 2016 also include:
- A detailed review of our deviation and change control systems
- Introduction of root cause analysis and risk management
- implementation of a dedicated Technology Transfer department to support process and analytical validation.
Adherence to cGMP is imperative within the pharmaceutical industry and without compliance with the regulatory guidelines, the drug or vaccine may contain impurities, have unwanted side-effects or lack the intended therapeutic effect.
Based on the EU Directive 2003/94/EC, Current Good Manufacturing Practice (cGMP) is the minimum standard that medicines manufacturers’ must achieve in their production processes to ensure consistent high-quality products that are appropriate for their intended use and compliance with the requirements of both the production specifications and the regulatory Marketing Authorisation.
The FDA state that adherence to cGMP regulations assures the identity, strength, quality and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes:
- Implementing robust quality management systems
- Obtaining the appropriate raw materials
- Establishing robust production operations
- Detecting and investigating product quality deviations and
- Maintaining reliable testing laboratories
Currently there is no requirement for chromatography adsorbent producers to adopt GMP for the manufacture of bio-separation absorbents as they are not considered a starting material, a final product or an active pharmaceutical ingredient by the pharmaceutical regulatory authorities. However, chromatography adsorbents are usually critical to the manufacture of bio-pharmaceutical products as their performance directly impacts the yield, purity and activity of the purified product. At Astrea we take our quality systems and product quality very seriously indeed which is reflected in the growing use of Astreas bioseparation products and currently over 18 of Astrea’s products have been incorporated into the manufacture of 15 regulatory-approved final products.
Although there are further steps to take to be fully GMP compliant by the end of 2018, we have taken significant steps towards this objective and recent audits by both small and large Pharmaceutical companies have verified that PBL’s QMS is sufficient from a GMP perspective.