Essential Elements of a Quality Management System

A good quality management system in a				how to categorize the deviations between production,
pharmaceutical company can significantly improve the				audit, quality improvements, technical deviations,
net profit status, high quality medicines for patients, less				customer complaints and environmental, health and
rework and recall which save more money, good				safety deviations. It should also describes the
work environment and compliance with local and				management responsibilities of initiating deviation,
international regulations.				capturing data, analysis, investigation, determination of
Quality management is a philosophy. It takes				assignable cause/s, generation of management report
management understanding, commitment and				and initiatives to be taken on corrective and
responsibility before introducing and implementing the				preventative actions.
concept. Once practiced a good quality management				Vendor Selection and Evaluation
system slowly develop or reshape a sustainable				Procedures to be followed during the vendor
organization culture that pays off rapidly.				assessment and vendor evaluation for purchasing of
The initial step of introducing a good quality				raw materials, critical and non critical packaging
management into a system is to know the essential				components, laboratory supplies, engineering supplies
elements of the quality system and clear study from				and imported finished goods from the vendor. These
where to start. Company objectives should be clearly				instructions are essential for approving prospective
understood. Policies should be prepared. Then comes				vendor.
the design of the process flow, validating the process,				Vendor Certification
material flow and organization chart. When a good				This procedure aims to describe the process by which
integration between people, process and material is				a vendor may be certified to supply materials or
achieved the next step is to putting the integrated				services. This procedure applies to vendors that supply
system in a state of control. Any deviation from the				a material or service to be used at any stage of
controlled system must be analysed and corrected.				manufacture by operations. Here you will describe the
Some basic but essential elements of Quality				roles of each department in the process to certify an
Assurance as depicted in GMP guidelines and ISO				approved vendor.
9001 guideline for pharmaceutical industry can be listed				Product Complaint Procedure
as: the Preparation of standard operating procedures				You should have strong procedure to cover the
of a complete system maintaining cGMP principles;				receipt, logging, evaluation, investigation and reporting
Preparation and maintenance of effective change				system of all complaints received from customers for
control of quality and master file documentation;				the marketed products. This procedure should contain
Recording and management of manufacturing change				step by step instruction to be followed during the
control; Recording and reporting procedure of				customer complaint management like numbering of
Deviations of your systems; Quality concern				complaint, registering the complaint, evaluation,
investigation process; Customer complaint investigation				determination of assignable cause for the complaint
procedure; Quality audit procedures; Vendor				deviation, implementation of corrective and
assessment, evaluation and certification procedure;				preventative actions, trending of complaints and
Quality control laboratory procedure, Rework				handling of counterfeit products.
procedures for the defective manufactured products;				Annual Product Review
Procedures on training for manufacturing staffs and				Some countries require reports as Annual Product
recall procedure.				Review to sell your products into their market. So you
Standard operating procedures and manuals should be				have to create instructions on how to do annual
written in details and referenced to relevant other				product review, to evaluate data, trends and to identify
documents, so a new starter within the organization				any preventative or corrective action that would lead
should be trained easily and expected to perform as				to product quality improvements and report them to
per procedure. The result will be a common standard				management.
of activities across the organization, good tractability of				Rework Procedure
work flow, deviations and ease of corrective actions				Procedure should contain the step by step instructions
as necessary.				to be followed when the rework of an in-process or
Standard Operating Procedure				completed finished good is required. Product
You should prepare SOPs, forms, templates and				Identification and Traceability The purpose of this
manuals, which can be used immediately as the				procedure is to define the method used for the
system runs. Forms and templates should be used for				identification of all contributing materials that could
record keeping which your people can follow routinely.				affect product quality and to ensure their full
Documentations - Classification, Definition and Approval				traceability.
Quality and Technical/Master file documents to be				GMP Audits
created to build up a good quality management				Procedure should be created to describe the process
system for your manufacturing sites. Definition of				of planning, performing, reporting and follow-up of
documents, their classification, approval requirements				different audits for your systems like Internal Quality
and retention requirements should be understood.				audit, Vendor audit, Environmental Health and Safety
Quality Documentation Management and Change				(EHS) audit, EHS workplace inspection, Housekeeping
Control				audit.
Procedures to be created on how to generate new				Evaluation of Batch Documentation and Release for
quality documents or change control of existing				Sale
documents, review of quality documents, satellite file				This procedure should describe the process of
management, role of document author, approver,				collection, evaluation and record of batch related
document control officer and satellite file administrator.				document generated during the production of a batch
In this procedures you will also define the numbering				before an authorized person can release the batch for
systems of different quality documents like audit files,				sale.
SOPs, forms, templates, manuals, training files, QA				GMP Training
agreements, project files etc and their effective				Effective GMP related training modules to be created
archiving system.				for your manufacturing staffs. Training records and
Preparation, Maintenance and Change Control of				reports have to produce on each employee as
Master Documents				justified.
Procedures to be created which will particularly focus				Management and Control of Contract Work
on the management of master file documents like				There should have procedure to describe the
specifications, control methods, raw materials, finished				management and control of contract work provided
goods and packaging specification and test reports,				by the contractors for packaging and finished products
formulation, stability files etc required to generate during				for your company as well as control of contract
the product registration in the market.				works done by your company on behalf of others.
Deviation Report System				Quality Concern Investigation Process
It is a regulatory requirement to capture all sorts of				Procedure should be made that contains instructions to
deviations evolves in your systems in order to maintain				follow when conducting Investigations collection of data
the continuous improvement of your processes and				and information, analysis, assigning root cause,
systems. Procedures should be created that describes				determine corrective and preventive actions.

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Essential Elements of a Quality Management System