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Continuation of a process step after an in process control test has shown that the step is incomplete is considered to be part of the normal process. The impurity profile should include the identity or some qualitative analytical designation e. Precautions to avoid contamination should be taken when apis are handled after purification. Manufacturing and laboratory records should be kept at the site where the activity occurs and be readily available. The validation protocol should specify critical process steps and acceptance criteria as well as the type of validation to be conducted e. This is not considered to be reprocessing.

Where physical attributes of the api are critical e. 2 all utilities that could affect product quality e. The final disposition of rejected materials should be recorded expiration dating for laboratory reagents and solutions. Equipment should be constructed so that surfaces that contact raw materials intermediates or apis do not alter the quality of the intermediates and apis beyond the official or other established specifications. For intermediates or apis with an expiry date the expiry date should be indicated on the label and certificate of analysis. Fresh and recovered solvents and reagents can be combined if adequate testing has shown their suitability for all manufacturing processes in which they may be used.

Complaint records should include name and where appropriate title and phone number of person submitting the complaint complaint nature including name and batch number of the api date complaint is received any follow up action taken final decision on intermediate or api batch or lot records of complaints should be retained to evaluate trends product related frequencies and severity with a view to taking additional and if appropriate immediate corrective action. Any person shown at any time either by medical examination or supervisory observation to have an apparent illness or open lesions should be excluded from activities where the health condition could adversely affect the quality of the apis until the condition is corrected or qualified medical personnel determine that the person s inclusion would not jeopardize the safety or quality of the apis. Companies should evaluate any contractors including laboratories to ensure gmp compliance of the specific operations occurring at the contractor sites.
If equipment is dedicated to manufacturing one intermediate or api individual equipment records are not necessary if batches of the intermediate or api follow in traceable sequence expiration dating for laboratory reagents and solutions. Any deviation from established procedures should be documented and explained.



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