1. Develop/Upgrade your Quality Management System (QMS) in accordance with diverse regulatory requirement.
2. Prepare/Upgrade your Standard Operating Procedure (SOP) to achieve better efficiency and uniformity of performance while reducing failed attempts to comply with industry regulations.
3. Upgrade/Review Product Quality Review to verify appropriateness of current specifications for both initial substrate material and final formulated product.
4. Review/Support of Pharmaceutical Product Quality investigation ensuring that the results of product and process monitoring are taken into account in batch release. Report of deviation will be analysed and updated with a view of preventive action to avoid potential deviations might occur in the future.
5. Conduct gap analysis audits and reviewing every phase of manufacturing process highlighting variances/deviation between current industry operation and standard regulatory requirements while updating to take intense measures to correct the variances in order to ensure that the industry produces products meets the highest quality standards.
6. Perform internal audit to assure the company performance by examining the company’s internal process around manufacturing, formulation, testing, supply, administration, accounting and general IT.
7. Validation and qualification of all equipment that is directly used in the manufacturing product as well the instrument / equipment that indirectly placed to support the process including Laboratory Instruments.
8. Guide/prepare site and staff for inspection provided with clarity insights regarding the whole process they perform and its purpose.
9. Review/compose your well scripted Technical agreement specifying the roles and responsibilities of respective parties related to production and control of the products ensuring compliance to the cGMP regulations.