equilab quality

Quality System

Our ISO 17025:2005 quality system, resources, and facilities are managed to meet the regulatory authority requirements and international standard for GCP, GLP, and BA/BE study to ensure the acceptance of our study report by Drug Regulatory Authority in many countries including regulated market, hence Equilab can support customer needs to export their product in many countries.

Our Quality Assurance ensures that BA/BE study is performed in compliance with the general regulatory requirements and international standards for BA/BE study that covers the clinical and analytical aspect.

According to the national regulations, the whole aspect and step in BA/BE study have been regulated and well explained in the complete guidance ”Pedoman Uji Bioekivalensi” published in 2004 by National Agency of Drug and Food Control Approval (BPOM). We also adopt Guideline from EMEA, FDA, and ASEAN (see our Guideline)

Our functioning Quality Assurance personnel rigorously inspect and monitor every aspect of those respective standards.

QA in Clinical Aspect
Our SOPs that related to the clinical activity comply with the Good Clinical Practice (GCP), an international standard for clinical trial that have been adopted from International Conference Harmonization (ICH) subtopic E-6. Equilab also refers to WHO Technical Report Series, No. 937, 2006., Annex 9: Additional guidance for organizations performing in vivo bioequivalence studies; WHO Technical Report Series, No. 850, 1995, Annex 3: Guidelines for good clinical practice (GCP) for trials on pharmaceutical products; and EMEA guidance related to the implementation of GCP Inspection as a practice guideline to develop the clinical procedure in performing BA/BE study and Clinical Trial.

QA in Analytical Aspect
To perform the reliable result in BA/BE Study, the bioanalytical techniques conducted in Equilab are accredited with ISO/IEC 17025:2005 and apply Good Laboratory Practice (GLP) requirements. As a reference and general recommendations in developing bioanalytical method validation and procedure, Equilab adopts the “Guidance for Industry Bioanalytical Method Validation” from EMA (European Medicines Agency), July 2011.

ISO/IEC 17025 Accreditation
PT Equilab International become the first BA/BE laboratory in Indonesia that has been awarded ISO/IEC 17025 certification from The National Accreditation Body of Indonesia (KAN). This accreditation also has important meaning to Equilab position in regional and international since in July 13th 2005, KAN and ILAC (International Laboratory Accreditation Co-operation) signed ILAC Mutual Recognition Agreement (MRA) Mark License. In addition, ILAC it self, which consists of 58 accreditation body including KAN, has signed the multilateral agreement with European Co-operation Accreditation (EA), International Accreditation Forum (IAF), and APLAC (Asia Pacific Laboratory Accreditation Cooperation). With these agreements KAN accreditation certificate is recognized by ILAC, EA, IAF, and APLAC member and it is equivalent with those accreditation certificates, thus the quality of BE study conducted by Equilab is accepted in Europe and Asia Pacific.