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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 Ch.M.& WHO-GMP certification.
  • Quality Assurance is independence of Manufacturing.
  • In-Process quality is checked during manufacturing.Validation of facilities, equipment’s, 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.

Address

816/1, Pramukh Industrial Estate, Science City-Rakanpur Road, Gandhinagar-382721 (Guj.)

Phone

+91 - 972311 3334

Email

rhombuspharma@gmail.com
inquiry.rhombus@gmail.com

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