Standard operating procedure for reprocessing of Intermediate or API & Intermediate, which does not confirm to the standards or specifications.
1.0 OBJECTIVE:
To lay down the documented procedure for establishment of Quality Assurance System in the Organization.
2.0 SCOPE:
This SOP shall be applicable for the proper implementation of the Quality Assurance System.
3.0 RESPONSIBILITY:
3.1 All Q.A. Personnel.
4.0 ACCOUNTABILITY:
4.1 Head of Quality Assurance Department.
5.0 PROCEDURE:
5.1 Ensure all operation in Production /QC/Stores are performed in accordance with the relevant cGMP guidelines.
5.2 To accompany External audit personnel during inspections are prepare corrective action plan in conjunction with Production /QC/Stores and ensure implementation of corrective actions.
5.3 To approve all master documents BMR, MFR, MSDS, and Specifications, SOP, Validation Products and reports.
5.4 Approve the artwork in co-ordination with Quality Control Department, Packing Development Department and Production.
5.5 To issue BMR each page having unique signature for authenticity.
5.6 To review and control BMR and QC data for each batch of product and give final release before dispatch for the product.
5.7 To ensure that no changes are made in formula, process without information and approval from license holder/customer. In order to regularize change in equipment, facility, utility, packaging and analytical procedure, raise change control for approval.
5.8 To co-ordinate all validation activities associated with production and QC i.e. process, equipment, utility, analytical method, testing equipment.
5.9 To prepare schedule and perform internal audits to ensure GMP compliance. Corrective Action Plan to be put in place for the observation and shall be filed.
5.10 To register all customer compliant and co-ordinate investigation activities with QC/Production and to prepare final report.
5.11 To provide relevant cGMP training to new entrants and retraining to all qualified production /quality control staff.
5.12 To keep track of technical training schedule of Production /QC and keep detailed training file for all such activities.
5.13 To handle all out of specifications results as per SOP.
5.14 To ensure all relevant QA in-process checks and line clearance are performed in day to day production activities.
5.15 To review and check periodically:
5.15.1 Maintenance schedules.
5.15.2 Pest control schedules.
5.15.3 Stability test results.
5.15.4 Calibration of equipments.
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