23.Feb .2022 23:00

Is GM Pharma ready to meet GMP standards?

Is GM Pharma ready to meet GMP standards?
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"A pharmaceutical company operating according to Good Manufacturing Practice (GMP) standards should have a quality control department as an independent entity. The department has one or more laboratories to ensure that all quality control measures are carried out efficiently and effectively. GM Pharmaceuticals has two quality control laboratories - a physicochemical and microbiological control laboratory.
 
The function of laboratories includes:
 
  • Receipt or control of raw materials,
  • As well as routine analysis in the control of intermediate and finished products,
  • Monitoring/control of environmental conditions of the enterprise,
  • Validation/verification of methods,
  • Process / delay / cleaning validation analyzes,
  • Also participation in the study of any inconsistent results as well as participation in the study of deviations.
 
The laboratories are equipped with the latest equipment. We cooperate with companies such as: Shimadzu, Sartorius, Mettler Toledo, Weiss and others. I will also point out that the quality control lab is working in accordance with primary standards such as European, American, LGC primary standards.
 
Up to 850 tests are conducted monthly in the quality control laboratory and up to 650 tests in the microbiological laboratory. 
 
GM Pharmaceuticals has been based on Good Manufacturing Practice (GMP) requirements since its inception, as evidenced by numerous inspections and audits by regulators in various countries.
 
The company holds several certificates of quality compliance: Certificate of Conformity of Production with GMP by British company hearthside Information Services Ltd since 2007, as well as Certificate of Good Manufacturing Practice GMP PIC / S issued by the inspection of the Ukrainian regulatory body since 2014, which is required for export. 
 
I would also like to add that the company produces more than 100 products in 10 countries around the world. An official representative office has been opened in 5 of them, where more than 200 people are employed.
 
It is planned to add representation in several more countries shortly.
 
Since 2004 the company's quality assurance system has been awarded the ISO 9001 certification of compliance with the international standard.
 
Since 2008, GMP Quality Control Laboratory has been accredited by the National Accreditation Authority for ISO 17025 compliance, and since 2019, the laboratories have undergone microbiological control. Laboratories undergo annual audits every year to maintain their accredited status.
 
We have submitted an application for compliance/certification with the Georgian National GMP standard. For this purpose, the company is scheduled for the National Regulatory Authority inspection in March 2022.
 
Having well-qualified staff in both production and laboratories is one of the requirements of the GMP standard and is the direct responsibility of management.
 
Staff selection is a multi-step procedure and the sources are varied, including the higher education institutions in the country.
 
The company has signed a memorandum with the Faculty of Pharmacy of the Medical State University, which allows graduate students to use the quality control laboratory as infrastructure as well as human resources for master studies.
 
The training system implemented in the company and consequently in the laboratories ensures the training of qualified staff, with the involvement of invited specialists and foreign consultants.
 
Staff competency is assessed by participating in the practical results of these exercises, as well as in qualification tests - by participating in annual inter-laboratory and in-laboratory comparisons of blind samples.
 
Both laboratories participate in international inter-laboratory studies in an average of 3-3 rounds per year with a pre-written and agreed plan.
 
A lot of research has been conducted. the next 2 years are planned with the help of the global and leading British company in the field - LGC Group.
 
Based on these and other criteria, the teaching process is evaluated and measures are taken to improve the system.
 
Part of the development of the laboratory staff is the periodic two-way feedback between the laboratory staff and the immediate supervisors to identify their and the company's development needs and to address other relevant issues," - GM Pharma representative tells BMG.