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Quality Plans

A quality plan has prepared by quality assurance for each finished product manufacture by the company.

The quality plan describes how specified product quality is achieved through quality system by either describing the method or by referring relevant documented procedures.

The quality plan is prepared in the form of a flow chart describing the requirements from receipt of the raw materials to delivery of products to customer and addressing of customer complaints

The quality plan flow chart addresses following requirements.

All applicable standards of ISO 9002 quality system by reference to respective procedures.

Identification of specifications and test methods for raw materials, intermediates and finished products.

Identification of In-process specifications and test methods.

Process instructions.

Identification of key equipments and measuring instruments fit for the purpose.

Identification of test equipments, instruments and any new techniques.

Identification of relevant quality records.

Any special training requirements.

Packaging and storage requirements for finished products.

Monitoring of stability of finished product dispatched to market.

System to address customer complaints and recall of product from market.

Quality Policy

KREBS BIOCHEMICALS & INDUSTRIES LIMITED manufacturing bulk drugs is committed to customer delight through supply of products that meet world class quality which includes competitive prices and committed delivery schedules.

We shall focus the following areas in our thrust to achieve global leadership in our business.

Implement current good manufacturing practices (cGMP)

Compliance with ICH requirements.

Respond to customer complaint / queries and feed back immediately.

Development of vendors.

PERSONNEL AND ADMINISTRATION FUNCTIONAL DEPARTMENTS

Personnel and administration

Research and development

Quality assurance

Purchase

Warehouse

Engineering service

Quality control

Production