Pre-Production Check
Pre-production inspection
Prior to product manufacturing, inspectors rigorously inspect all production materials, components, and processes in strict compliance with client specifications. They meticulously compare manufactured products against client-approved samples to ensure perfect alignment. This phase serves as our commitment to maintaining sample accuracy and production method correctness, while identifying risks to prevent resource waste and assisting clients in developing improvement plans.
Purpose of pre-production inspection
The core objective of pre-production inspection is to mitigate initial production risks and ensure the feasibility of production plans and quality standards, which specifically includes:
--Confirm that raw materials, components, and excipients meet the specified specifications and quality requirements.
--Confirm that the production process, procedures, and equipment are ready.
--Verify that production samples meet order requirements
--Early identification of factory capacity or production capacity constraints risks
--Lay the foundation for quality control during the production phase (DPI)
--Avoid rework and losses caused by inadequate pre-production preparation
Key points of pre-production inspection
--Verification of critical materials and material lists;
--Confirmation of mass production samples;
--Customer requirement confirmation;
--semi-finished products and some finished products;
--Production line and production capacity;
--Factory machinery and equipment;
--Production environment ;
--Risk Assessment and Rectification Recommendations
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