QA Incharge & Management Representative (MR) is responsible for maintaining total quality of systems and products as per GMP requirements.
We, has been implemented quality management system since 2007. The quality management system are consist of one unique quality manual, mandatory quality procedures by the standard and standard operating procedures for the manufacturing and allied activities like management review meeting, marketing, purchasing, vendor approval & performance evaluation, training and quality control.
Major responsibilities covers:
- Ensure compliance of national and international regulatory GMP requirements and ISO standard’s requirements
- Ensure availability of approved procedures and specifications for reference.
- Review Batch processing and testing records, before giving product release.
- Review and authorize Validation master plan, Protocols and provide support for validations
- Ensure compliance of Change control procedures.
- Carry out process controls, including in-process checks / inspections / line clearance.
- Investigate complaints, deviations, quality incidents and non- conformances.
- Handling of regulatory inspections at the site.
- Take actions on product recalls and investigate the reason.
- Ensure implementation of pest and rodent controls, as per defined schedules.
- Review product stability reports. Review batch manufacturing records, verify reconciliation of batch inputs, batch yields and finally release the product.
- Annual Product Quality Review
- Vendor development and approval
- Internal audit
- To review and approval of master validation program, including equipments, processes, facilities, analytical methods etc.
- To investigate out of specification results or failure investigation related to testing or manufacturing etc.
- To ensure sampling of raw-materials and packaging materials as per company procedures.
supply of validation batches:
Mr. Rajesh Shah who is the QA in charge is the authorized person for the batch release for the sale. He has bachelor of commerce and having work experience of 25 years for the same product and activities in the same industries. He is assisted by Mr. Paresh patel who is a QC incharge. He has passed B.com having work experience of 6 years for the same product in the same industries.
Validation Batches shall be released for sale, provided;
- Product complies with all pre-determined specifications (In process, Intermediate, Finished).
- Batches are manufactured as per the defined process & parameters.
- No evidence of any deviation.
- Review of batch manufacturing records, analytical reports, validation reports, environment conditions do not reveal any deviation to defined standards.
- Batches are kept on stability studies
- Customer Approval.
Management of suppliers and contractors
A documented procedure is prepared and implemented for the approval, assessment, and evaluation of vendors. All materials used at the site are obtained from “APPROVED VENDORS” only.
Below is a summary of the activities necessary for the approval of a vendor:
- Vendor assessment through questionnaire
- Audit
- Placing work order
- Performance evaluation
Main purchase of the organization is raw material (psyllium seeds), packing material, machinery, equipments and personal protective equipments (PPE).
The raw material (psyllium seeds) is purchased by our own company from the agriculture produce market committee, Unjha, North Gujarat, India.
The packing material include jute bags, paper bags with liner, HDPE bags, fiber drums and FIBC bags from the approved suppliers.
The organization does not purchase any active substance product for the manufacturing and/or as processing aids.
Vendors for packing material are assessed through questionnaires, which is designed to understand the standards followed by the vendor. Vendors supplying packaging material are audited once in 3 years,
The organization has sub-contacted the activities like pest management services, laboratory services for the testing of the products, steam sterilization, ETO treatment, fumigation, calibration services for the equipments. (Appendix 4)
We have been following the procedure for the selection and approval of the above mentioned sub-contracted activities.
We keep the updated copy of applicable legal license / certificates for the above mentioned sub-contractors.