Process Validation
This SOP describes the procedure to be followed for Process Validation of manufacturing process used for manufacturing product.
SOP + EDITABLE TEMPLATES₹119View SOP →
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Quality Assurance SOP templates
Quality Assurance SOP templates focused on CAPA, complaints, vendor control and review-driven quality-system work.
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Focused SOPs for Quality Assurance.
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Practical reading: BMR review checklist with example findings — a free guide to reviewing an executed batch record.
Reprocess and Reworking of API’s and Intermediates
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.
SOP + EDITABLE TEMPLATES₹59View SOP →
Product Recall
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.
SOP + EDITABLE TEMPLATES₹129View SOP →
Preparation & Control of FG Labels
The objective of this SOP is to lay down a procedure for Preparation and control of Label for finished product Dispatches.
SOP + EDITABLE TEMPLATES₹99View SOP →
SOP for Handling of Out of Specification
This SOP describes the Procedures for Investigation and documentation to be carried out for any Out of Specification test results.
SOP + EDITABLE TEMPLATES₹999View SOP →
SOP for Handling of Deviation
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.
SOP + EDITABLE TEMPLATES₹499View SOP →
SOP for Good Documentation Practices
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.
SOP + EDITABLE TEMPLATES₹499View SOP →
SOP for Cleaning Validation
This SOP provide guidance for the validation of cleaning procedure in order to comply with cGMP and Regulatory requirements.
SOP + EDITABLE TEMPLATES₹299View SOP →
SOP for Control of Documents
This SOP lay downs a procedure for Control of Documents.
SOP + EDITABLE TEMPLATES₹99View SOP →
SOP of Change Control System
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
SOP + EDITABLE TEMPLATES₹179View SOP →
SOP for Calibration Program
This SOP is to establish and maintain a system for the calibration of all instrumentation.
SOP + EDITABLE TEMPLATES₹89View SOP →
SOP for Training
This SOP describes the procedure for imparting training to all the technical staff employees in the organization.
SOP + EDITABLE TEMPLATES₹119View SOP →
SOP for Handling of Market Complaint
Handling of Market Complaint
SOP + EDITABLE TEMPLATES₹259View SOP →
SOP of Batch Manufacturing Record (BMR)
Issuance and Control of Batch Manufacturing Record (BMR).
SOP + EDITABLE TEMPLATES₹129View SOP →
SOP for Vendor Qualification
This SOP describes the procedure for Assessment, Evaluation and approval of vendor of Raw Material and Packing Material.
SOP + EDITABLE TEMPLATES₹899View SOP →