2024年4月9日发(作者：诺基亚e72i能用微信吗)

Quality Assurance (QA) Management Procedures

In this episode you will find procedures and practical work instructions on every aspect of Quality

Assurance and Technical areas to build up a highly effective Quality Management System for

your pharmaceuticals business.

In this area 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.

SOP list

QMS-005 How to Write Standard Operating Procedure

This SOP describes standard SOP format that you can use immediately for your quality

procedures. This SOP has instructions on how to write a formal Operating Procedure for your

systems which your people can follow everyday.

QMS-010 All Documents - Classification, Definition and Approval Matrix

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.

QMS-015 Quality Documentation Management and 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.

QMS-020 Documentation Rule for GMP Documents

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.

QMS-025 Quality Documentation - Control, Tracking and Distribution

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.

QMS-030 Preparation, Maintenance and Change Control of Master 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.

QMS-035 Deviation Report System

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.

QMS-040 Shelf Life of Product

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.

QMS-045 Vendor Selection and Evaluation

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.

QMS-050 Vendor Certification

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.