PQMS offers following services which are designed based on Client- specific needs
to achieve Total Quality Compliance (TQC) :
- Site Quality Audit Services - This service will include Pre , Post or Regular
Quality system audit of a site for the suitability of manufacturing & Testing/Release
of the product at this site. This will generate a comprehensive report of the Audit
covering the different critical functions performed at the site like, Stores (RM/PM/Quarantine),
Quality control ( Test methods and specifications used to test the manufactured
batch, instrument calibration status), Production ( manufacturing process used,
validation status of the process used, etc.) Stability Protocol/ Facility, Personnel
Training, Equipment Maintenance, etc. functions to ensure the Quality Compliance
of site towards manufacture & Testing / Release of the product from the site for
sales.
This Quality Audit of the Site will ensure compliance of each of the manufactured
batch at the site and hence will save cost of recall & destruction of a non-compliant/
failed batch of product, cost of investigation and trouble shooting of the complaints,
cost of losing image of the brand/Company.
- Product Registration Dossier Management - PQMS will take up complete responsibility
of Registration Dossier preparation, submission and query handling as per the Client
needs and Formats. This will include CTD, Non-CTD, ACTD, any other format.
- Independent Quality Audits (IQA) – PQMS will carry out in-depth audit of
the Quality control Laboratory function to help you receive various regulatory authorities
Compliance
- Quality Document Management (QDM) – PQMS can on-line Prepare & Review all
Quality Documents like Batch Manufacturing & Packing records, Validation Protocols/
Reports, Stability Studies Report/Data compilation, any other Summary/ Report preparation
as per your needs to significantly reduce your cost & time towards these mandatory
regulatory tasks.
We can take up Annual / Long-Term Contract for all above regular documentation Services
- Training - Training to your people on any Quality topic as per your Training
Calendar and Training Matter. This service will save your valuable Resources/Time
towards Regulatory Compliance towards the Employee Training requirements. PQMS can
take up Annual / Long-Term Contract for this Service.