Process Validation
This SOP describes the procedure to be followed for Process Validation of manufacturing process used for manufacturing product.
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This SOP describes the procedure to be followed for Process Validation of manufacturing process used for manufacturing product.
The objective of this SOP is to lay down for reprocessing/ reworking of any API and Intermediate which does not conform to standard or specification.
The objective of this SOP is to effective and speedy recall of product from Market/ Customer/ Distributor during its shelf-life period or for corrective action for deficiencies that are impacting the SISPQ (Strength, Identity, Safety, Purity & Quality) of the product.
The objective of this SOP is to lay down a procedure for Preparation and control of Label for finished product Dispatches.
This SOP describes the Procedures for Investigation and documentation to be carried out for any Out of Specification test results.
This SOP is to describes the procedure for handling of deviations observed during manufacturing or from establish system/procedure and ensuring that the deviations are controlled, evaluated, authorized and closed with necessary actions to avoid its recurrence.
This SOP is to describe the procedure for good documentation practices while writing and recording work in a legible, traceable and reproducible manner of cGMP documents.
This SOP provide guidance for the validation of cleaning procedure in order to comply with cGMP and Regulatory requirements.
This SOP lay downs a procedure for Control of Documents.
this SOP is to outline the procedure for handling mechanism for the identification, documentation, appropriate review and approval of all ongoing process optimization changes or other changes that may affect the Manufacturing, Quality and Regulatory filings and any other approved
This SOP is to establish and maintain a system for the calibration of all instrumentation.
This SOP describes the procedure for imparting training to all the technical staff employees in the organization.
Handling of Market Complaint
Issuance and Control of Batch Manufacturing Record (BMR).
This SOP describes the procedure for Assessment, Evaluation and approval of vendor of Raw Material and Packing Material.