Implementing cGMP

POLYHEDRON assists in implementing cGMP norms in any Food and Pharmaceutical companies to make the activities of the company to comply with Standards of US FDA and other regulatory agencies.

Implementation of GMP involves Quality system design, Documentation, Process validation, Equipment validation, Warehouse controls, Laboratory controls, Process control, Deviation control, Failure investigation, Customer complaint handling, etc.,

 Analytical method development and validation

POLYHEDRON assists in developing of Analytical methods using TLC, GC, HPLC, UVS, FTIR, etc., Also, assists in validating the methods as per USP/ICH requirements.

Where required, Quality Plan will be prepared for an entire manufacturing process. The plan includes, nature and extent of testing required on incoming Raw material, stages at which in-process tests to be carried out and final product testing. Testing procedures and acceptance limits are also part of the quality plan.

 Stability studies

POLYHEDRON assists in conducting Stability studies as [er ICH norms. Stability study programme include, Stress testing, Development of suitable analytical methods, Selection of suitable environmental conditions, Schedule for testing and the Interpretation of results.

 Impurity profile study

POLYHEDRON assists in carrying out Impurity profile study for synthetic drugs. The study includes isolation and characterisation of the impurity.

 DMF preparation

POLYHEDRON prepares Drug Master File(DMF) as per the guidelines of US FDA / UK MCA / Eur Union / Canada / Australian TGA.

 cGMP audit

POLYHEDRON audits client companies or their suppliers for compliances to cGMP norms. POLYHEDRON's audits are always very extensive and bring out even minor non-conformities in the operation. As a value addition to its service, POLYHEDRON offers suitable corrective actions for the non conformities found. POLYHEDRON's audit service will be totally unbiased.

Further, availing of this service is very cost effective to US and European clients who wish to evaluate their vendors operating in Asian countries.

You are most welcome to contact us through the online form below for more details on our Service to manufacturers.
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