In this episode you will find Standard Operating Procedures for establishing quality assurance practices, such as preparation, maintenance, definition, classification and change Control of Quality and Master file documentation necessary for your products; recording and reporting procedure for deviations management; quality concern investigation Process; customer complaint handling procedure; quality audit procedures; vendor assessment, evaluation and certification procedure; rework procedures for the defect
In this episode you will find Standard Operating Procedures for establishing quality assurance practices, such as preparation, maintenance, definition, classification and change Control of Quality and Master file documentation necessary for your products; recording and reporting procedure for deviations management; quality concern investigation Process; customer complaint handling procedure; quality audit procedures; vendor assessment, evaluation and certification procedure; rework procedures for the defective manufactured products; procedures on training for your staffs and many other procedures according to your need.
All procedures have reference of prepared Forms and Templates for effective record keeping and reporting purposes. Forms are attached at the end of each procedure. Templates are listed separately.
Writing Standard Operating Procedure
This SOP describes standard SOP format that you can create and use immediately for your quality procedures. This SOP has instructions on how to write a formal Operating Procedures for your systems which your people can follow everyday.
In this SOP you will find all type of quality and Technical/Master file documents to build up a good quality management system for your manufacturing sites, definition of documents, their classification, approval requirements and retention requirements. This procedure has schematic diagrams for your understanding of how different types of documents are prepared and stored in a typical documentation database.
Quality Documentation Change Control
This SOP describes how to generate new quality documents or change control of existing documents, review of quality documents, satellite file management, role of document author, approver, document control officer and satellite file administrator. In this SOP you will also find numbering systems of different quality documents like audit files, SOPs, forms, manuals, training files, QA agreements, project files etc and their effective archiving system.
This SOP describes the principles to be followed in GMP documents, entry of data and information, signature requirements and correction technique of incorrectly entered data or information.
In this SOP you will find mainly the role of document control officer during the initiation, creation, circulation and approval of new quality related documents. It also describes the procedure of modification and review of existing document using a documentation database. Management of existing and superseded documents is also a part of this procedure. You will see all the forms referred during the instruction are attached at the end of the procedure.
Master GMP Documents
This SOP particularly focused on the management of master file documents like specifications, control methods, raw materials, finished goods and packaging specification and test reports, formulation, stability files etc required to generate during the product registration in the market. This SOP gives instruction on their creation, change control, numbering system, approval requirements and maintenance in a simple master file database. You will see all the forms referred during the instruction are attached at the end of the procedure.
It is a regulatory requirement to capture all sorts of deviations evolves in your systems in order to maintain the continuous improvement of your processes and systems. This SOP describes how to categorize the deviations between production, audit, quality improvements, technical deviations, customer complaints and environmental, health and safety deviations. It describes the management responsibilities of initiating deviation, capture data, analysis, investigation, determination of assignable causes, generation of management report and initiatives to be taken on corrective and preventative actions.
Product Shelf Life
This simple SOP describes the meaning of shelf life and provides direction on how to interpret shelf lives and storage conditions for your raw materials from the Certificate of Analysis, determining expiry date for your finished products by use of raw material date of manufacturing and their shelf lives.
This SOP describes the procedure to be followed during the vendor assessment and vendor evaluation for purchasing of raw materials, critical and non-critical packaging components, laboratory supplies, engineering supplies and imported finished goods from the vendor. These instructions are essential for approving prospective vendor.
This procedure aims to describe the process by which a vendor may be certified to supply materials or services. This procedure applies to vendors that supply a material or service to be used at any stage of manufacture by operations. Here you will get the roles of each department in the process to certify an approved vendor.
This procedure covers the receipt, logging, evaluation, investigation and reporting system of all complaints received from customers for the marketed products. This SOP contains step by step instruction to be followed in the customer complaint management like numbering of complaint, registration, evaluation of complaints, determination of assignable cause for the complaint deviation, implementation of corrective and preventative actions, trending of complaints and handling of counterfeit products.
This procedure provides a guideline to annual product review which is required to be performed for each product produced for the commercial market to evaluate data, trends and to identify any preventative or corrective action that would lead to product quality improvements and report them to management.
This SOP contains the step by step instruction to be followed when the rework of an in-process or completed finished good is required. This SOP covers the reworks of in-process manufactured goods where new batch number is introduced for the reworked part and rework of manufactured finished good keeping the same batch number. This sop also describes how to create rework protocols for each individual case.
Product Identification and Traceability
The purpose of this SOP is to define the method used for the identification of all contributing materials that could affect product quality and to ensure their full traceability. Here you will find instruction on all the records and documents used for the identification and traceability of incoming raw materials and outgoing finished goods.
This SOP describes the identification of all documentation relevant to a production process in the form of “Batch Documentation Checklists” and to ensure their collection by completion of the checklists by Authorized Persons. This procedure is based on an example of tablet packaging process described in the ‘Manufacturing’ category.
Batch Document Evaluation for Release
This procedure describes the process of collection, evaluation and record of batch related document generated during the production of a batch before an authorized person can release the batch for sale. This procedure is based on an example of tablet packaging process described in the ‘Manufacturing’ category.
This SOP describes the process of planning, performing, reporting and follow-up of different audits for your systems like Internal Quality audit, Vendor audit, Environmental Health and Safety (EHS) audit, EHS workplace inspection, Housekeeping audit. This SOP also describes the process to be followed by manufacturing personnel during an audit from a Regulatory authority.
This SOP describes how to design and deliver GMP related trainings for your manufacturing staffs, training assessment design, recording of assessment and preparation of training reports.
GMP Training Materials
This simple SOP contains instructions on how to write training materials, identification of training requirements, available resources, and preparation of training aid checklists for your manufacturing staffs.
House Keeping Audit
This SOP describes the requirements, checklists and reporting procedure on housekeeping audits. Individual checklist forms are attached at end of the procedure for different areas like process, laboratory, engineering stores, warehouses. This procedure also describes the handling of non-compliance found during the housekeeping audits.
The procedure describes the management and control of contract work provided by the contractors for packaging and finished products for your company as well as control of contract works done by your company on behalf of others.
Raw Material and Packaging Components Sourcing
The purpose of this SOP is to describe the process for approval of an external vendor/manufacturer supplying products to your company. It covers raw materials (including bulk products for subsidiaries and contract manufacturers), critical packaging components in contact with product and imported finished goods. The SOP also references affiliated documentation detailing the scope of active materials used and the approved manufacturers of these materials.
Quality Investigation Process
This procedure contains instruction to be followed when conducting Investigations and to raise and assess Deviation Report when an Investigation or Incident Investigation occurs. This procedure is to be used in conjunction with Deviation management, which covers the approval and follow-up activities associated with a Deviation Report. Here you will find collection of information for an incident or a deviation, steps to be followed for a cross functional investigation, reporting and implementing of the outcomes of investigation.
Change Management System
This procedure provides a standardized procedure and framework for initiating, authorizing, planning and implementing any change to a GMP system.
Product Change Management requires that all planned permanent changes that have the potential to impact on regulatory filings or the quality of an active pharmaceutical ingredient or drug product must be evaluated, reviewed and approved. It also requires that the site procedure must include provision for effectively tracking all quality and regulatory changes and provide a mechanism for review and approval by the Site Quality Team for all changes
Cross functional investigation
This procedure describes the guidelines for initiating, communicating, conducting and documenting Cross-Functional Investigations (CFI) related to process, system, product, material, facility and laboratory deviations. A Cross–Functional Investigation is an extended investigation conducted in order to identify a Root Cause.