We will establish Quality management systems as required by International regulatory authorities like USFDA, MHRA, WHO Geneva and etc. This includes the following:
- Preparation of standard operating procedure for various departments, like warehouse, Quality Control, Production, packing, Quality assurance and engineering by using quality management tools.
- Training of the personnel for the standard operating procedures.
- Establish preventive maintenance systems
- Establish requirements for calibration of instruments and components of equipments
- Help in designing process validation, cleaning validation systems
- Designing batch manufacturing records and batch packing records
- Design and implementation of formal quality management system by initiating quality risk management process.
- Gap analysis of QMS with international quality standards.
- Process mapping and assessment of critical control points.
- Designing of process validation and cleaning validation with complete coverage of all critical control points.
We have engineering associates with us who executed various product across the globe:
- Adcock ingram tablet facility in South Africa.
- Adcock ingram liquid oral facility in South Africa
Mode of Services
Services A
- Meeting with client.
- Identify Clients and respective regulatory requirements.
- Define QMS and make sure it’s implementation.
- Regular visits to for the verification of effective implementation of QMS.
Services B
- Meeting with client.
- Identify Clients and respective regulatory requirements.
- Define QMS and make sure it’s implementation.
- Appoint fulltime Sasaglobal team at the site for agreed period and our team implement all the defined action plan.
- Execution of this service gives tremendous reassurance that the GMP (as required by concerned regulatory agency) or requirements of the company are being implemented.
- Training & development by our seniors to client’s staff.
- Regular visits by our seniors for the scope of upgradation & scope of improvement as per current guidelines and industrial practices to compete in the market.