Our experts are addressing professionally and efficiently your various and demanding GMP requirements. We are able to offer individual niche solutions for your challenges as well as comprehensive packages that cover all your GMP requirements.
For start-ups, we provide the implementation of a quality management system with all mandatory documents (GMP & GDP). Furthermore, our team support the GMP-compliant definition of process steps and implementation with regard to rooms and equipment (GxP QMS, GAP Analysis, Qualification & Validation). With us, you obtain your manufacturing authorization and the corresponding GMP certificate within the shortest possible time and move your business idea forward as quickly as possible.
PLANT UPGRADATION
If you already have the API or Formulation Plant which is approved by the local regulatory authority and if you want to expand your reach to regulated territories like USFDA, EMEA, WHO, MHRA, PIC/S, etc. then you may choose for Plant Up-gradation Service.
Plant Up-gradation Includes the following:
- Establishment of Proper scope for which regulation is being targeted.
- GAP Audit of Existing Plant (API/Formulation)
- Preparation of GAP Audit Report,
- Preparation of CAPA Plan,
- Identification of GAPs and making time bound milestones for up-gradation
- Validation
- SOP and Procedures up-gradation,
- Training
- QMS system establishment/ restructuring as per requirement
- Internal Audit System development.
- Training: Our qualified & experienced Trainers provide training on all GXP topics like GMP, GDP, GLP, Data Integrity, QMS and many other critical topics which helps to enhance employees skill and operational performance.
AUDITS: Independent Supplier Audit: (GMP System and Facility Audit)
To evaluate the system and manufacturing facility in compliance with the regulatory expectation and quality standards. To ensure the capability of the facility to manufacture quality medicine. To determine the effectiveness of the Quality system implemented and adherence to the specified quality objectives.
- Vendor qualification/assessment Audit.
- Remote Audit / Virtual Audit.
- Pre-Inspection Audit
- GAP Audit
- QMS Audit