Due to limited man power, at times companies are not able to effectively conduct audit of their vendors/suppliers. MEDATEQ LABS. Offers audit support to companies who would like to outsource this task with a team of highly qualified & experienced professionals, we help our clients to find out the GAPS within their organizations based on four criteria viz-infrastructure, systems, documentations and manpower capacity & capabilities. This supports them to upgrade their standards so as to meet current regulatory norms.
Our auditing services provide powerful and effective recommendation for numerous major pharmaceutical manufacturers as well as for smaller companies and facilities. With our "mock" FDA pre-approval audits we can help to ensure that problem areas are identified and addressed before the real inspection. We conduct audits to evaluate and advice on adequacy of current Good Manufacturing Practices (cGMP) & Good Quality Control Practices, compliance programs for intermediates, active pharmaceutical ingredients (APIs) & finished drug products. Necessary corrective and preventive actions shall also be mentioned in our audit reports. Because of our experience, we are able to provide simple & pragmatic advice for all the major International Regulatory and GMP standards including EU, USA, Canada, Australia, WHO and more.
MEDATEQ LABS conducts third party audits like vendors of active substance, formulations, excipients, packing materials etc. Such audits, conducted periodically, will help to maintain good relationship between the suppliers and buyers. our professional team of qualified auditors with experience will apply their technical expertise to ensure vendor compliance and trained auditors are to perform audits as per standards:
Schedule –M
US 21 CFR 210-211 (cGMP) for API, Intermediates, Raw Materials
US 21CFR 820
EU GMP Part 1 with Annex 10 for Sterile Medical Devices and Medical implantable devices
EU GMP part II for API (ICH Q7)
EU GDP for API
EU IPEC GMP
EU IPEC GDP for Pharmaceutical Excipients
EU GDP for Medicinal products
ISO 15378
ISO 9001 for Chemical manufacturers
ISO 22716 for Cosmetic Ingredients
ISO 13485
MEDATEQ LABS auditors have cumulative auditing experience of more than 450+ audits. Audit reports of our auditors are accepted across the globe and reviewed during regulatory inspections.
cGMP Consulting Services
GMP Gap Analysis Audit
GMP Training
DMF/Dossier Preparation
Quality Management Systems
Technical Document Writing
Vendor Audit
Documentation
Our expertise is in the following types of audits:
Third Party Audit
Pre Approval Audits for EU and US Inspection.
Bench Marking Audit
GMP audits of Active Pharmaceutical Ingredients and Drug Products
Audits of Contract Research Organizations
Audits of QC & Contract Testing Laboratories
