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Quality Assurance ::
Torrent's quality policy is mandated and supported
by the Executive Management and coordinated by
an independent Corporate Quality Assurance (CQA)
Department.
Highlights ::
- First Indian pharmaceutical plant to get
ISO 9001, ISO 14001 & OHSAS 18001certification.
- 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
Torrent Research Centre (TRC).
- Distribution of documents received from TRC.
- Checking & approval of documents generated
based on TRC 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.
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