Quality Assurance

Rhombus Pharma Pvt. Ltd. quality policy is mandated and supported by the Executive Management and coordinated by an independent Quality Assurance (QA) Department.

Highlights

Pharmaceutical plant with ISO 9001, revised Sch.M & WHO-GMP certification.
Quality Assurance is independence of Manufacturing.
In-Process quality is checked during manufacturing.
Validation of facilities, equipment, process, products & cleaning as per Master Plan.
Complaint Handling.
Storage of quality record and control samples.
Stability Studies.

Quality Assurance Department handles the following activities:

Validation

Preparation of validation plans for facility / equipment/ 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

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

GST : 24AADFR3911N1Z5