QUALITY ASSURANCE:
Sehat Pharma’s quality policy is mandated and supported by the Executive Management and coordinated by an independent Corporate Quality Assurance (CQA) Department.
Highlights
- Quality Assurance is independence of Manufacturing.
- In-Process quality is checked during manufacturing.
- Validation of facilities, equipments, process, products & cleaning as per Master Plan.
- Complaint Handling.
- Storage of quality record and control samples.
- Stability Studies.
- Registration Documents (DMF)
Quality Assurance Department handles the following activities :
Technology Transfer
- Receipt of product design documents from Sehat Research Centre (SRC).
- Distribution of documents received from FRC.
- Checking & approval of documents generated based on FRC documents i.e. Batch Manufacturing Record.
- Scale-up and validation of product
Validation
- Preparation of validation plans for facility / equipments / process including cleaning.
- Approval of protocols for validation of facility / equipment / product / process.
- Team member for execution of validation of facility / equipment / product / process.
Documentation Control
- Controlled distribution and archiving of documents.
- Control of changes made by proper change control procedure.
- Approval of all documents
Assuring Quality of Products
- cGMP training
- SOP compliance
- Audit of facility for compliance
- Line clearance
- In-process counter checks
- Critical sampling
- Record verification
- Release of batch for marketing
- Investigation of market complaints
- Stability of products
Quality Improvement Plans
- Feedback received from the compliance team
- Proposals for corrective & preventive actions
- Annual products review
- Trend Analysis of various quality parameters for products, environment & water.
Following are the factors that help us to achieve the excellence in manufacturing with desired quality standards.
- Considering the Quality Standards while recruiting the Staff
- Confirming the Quality Checks of our Raw Material & Packing Material Vendors
- Monitoring the Man-Material Movement & Log-Sheets to confirm SOPs are followed properly
- Cleaning, Validation, & Calibration of the machineries & Instruments before change over
- Maintaining appropriate Health & Hygiene of Staff & Premises
- Procedures given in Batch Manufacturing Record (BMR) & Batch Packaging Record (BPR) are followed for manufacturing
- Raw Material Testing, In-Process Quality Testing & Final Product Testing is carried out to give quality products to client
- Customer Complaints are recorded & resolved with Corrective Action Plan
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