3. • Pharmaceutical Quality Management System (QMS) is a comprehensive
collection of policies, processes, and procedures designed to ensure and
maintain uniform and high quality in the production of pharmaceutical
products.
• Its primary objective is to prevent people and processes from diverting from
quality standards like ICH Q10 and ISO. An example of QMS is process
validation studies of pharma drugs that consist of data that ensures the
drug manufacturing process is carried out according to pre-defined quality
steps.
• A QMS helps coordinate and direct an organization’s activities to meet
customer and regulatory requirements and improve its effectiveness and
efficiency on a continuous basis.
INTRODUCTION
4. Increased operational efficiency
Reduced wastage
Superior quality products
Improved customer satisfaction
Reduced training time of new employees
Enhanced processes, products, and systems
Compliance with Industry best standards
Better internal dept. communication
BENEFITS OF QMS
5. IMPORTANCE OF USING A PHARMACEUTICAL
QUALITY MANAGEMENT SYSTEM
Quality Management System plays a very important role in pharmaceutical
industries as it ensures that the product satisfies customer specifications as well as
industry regulations. It uses quality assurance methods to prevent quality
deviations and emphasizes on documentation to keep track of all issues and
solutions.
An effective pharmaceutical QMS benefits businesses by establishing a quality
culture through its set of modules that ensure integrity, manage documents in less
time and cost reduction, faster develop products, easily identify plus resolve
problems, confirm supplier quality, and upskills workforce through effective
training
7. NON-CONFORMANCE MANAGEMENT
This feature of pharmaceutical QMS helps pharma
manufacturers in documenting all product issues identified
throughout the quality control process and helps in
ensuring that they don’t get repeated in future.
8. WHAT IS DEVIATION?
As per ICH Q7 Good manufacturing
practice for active pharmaceutical
ingredients, a deviation is defined as:
“Departure from an approved
instruction or established standard.”
9. TYPES OF DEVIATION
There are Two types of Deviations:
Planned Deviation
Un-Planned Deviation
• Note: All the planned deviations will be covered through
Change Controls.
11. DEVIATION CATEGORIZATION
MINOR DEVIATION: When the deviation does not affect any quality attribute, a critical process
parameter, or an equipment or instrument critical for process or control, it would be categorized
as Minor.
MAJOR DEVIATION: When the deviation affects a quality attribute, a critical process parameter,
an equipment or instrument critical for process or control, of which the impact to patients (or
personnel/environment) is unlikely, the deviation is categorized as Major requiring immediate
action, investigation, and documented.
CRITICAL DEVIATION: When the deviation affects a quality attribute, a critical process parameter,
an equipment or instrument critical for process or control, of which the impact to patients (or
personnel or environment) is highly probable, including life threatening situation, the deviation is
categorized as Critical requiring immediate action, investigated, and documented
12. Few Examples for Deviation:
Minor Deviation:
Skip of FEFO principle (first expired-first out) in raw material handling.
Pressure differential out of established limits in class D washing area.
Inadequately trained personnel to perform warehouse cleaning activities.
Major Deviation:
Production started without line clearance.
Unqualified equipment use for batch manufacturing.
Pressure differential out of established limits in aseptic fill areas.
Critical Deviation:
Expired or rejected API component used.
Temperature out of control limit during depyrogenation.
Out of calibration balances use for weighing / dispensing.
13. INVESTIGATION TOOLS
Investigation shall comprise of one (or more
than one) of the following investigation tools:
Brain Storming
GEMBA
Interview
5 Whys
Fishbone Diagram/ Ishikawa (6M)
14. OUTSOURCED ACTIVITIES
• Any activity covered by the GMP Guide that is outsourced should be appropriately defined, agreed and
controlled in order to avoid misunderstandings which could result in a product or operation of
unsatisfactory quality.
• There must be a written contract between the Contract Giver and the Contract Acceptor which clearly
establishes the roles and responsibilities of each party.
• The Pharmaceutical Quality System of the Contract Giver must clearly state the way that the Authorised
Person certifying each batch of product for release exercises his/her full responsibility.
15. AUDIT MANAGEMENT
The pharmaceutical industry can easily monitor and regulate
its auditing operations through this robust module.
Organizations can have a managed workflow of operations
like creation, scheduling, preparation, execution, tracking,
and updating on their yearly, half-yearly, and quarterly
audits using the pharmaceutical QMS Audit Management
System.
16. SELF INSPECTION
• Self inspections should be conducted in order to monitor the implementation and compliance
with Good Manufacturing Practice principles and to propose necessary corrective measures.
• Personnel matters, premises, equipment, documentation, production, quality control,
distribution of the medicinal products, arrangements for dealing with complaints and recalls,
and self inspection, should be examined at intervals following a pre-arranged programme in
order to verify their conformity with the principles of Quality Assurance.
• Self inspections should be conducted in an independent and detailed way by designated
competent person(s) from the company. Independent audits by external experts may also be
useful.
• All self inspections should be recorded. Reports should contain all the observations made
during the inspections and, where applicable, proposals for corrective measures. Statements
on the actions subsequently taken should also be recorded.
17. TRAINING MANAGEMENT
• The training management system helps businesses in identifying training
requirements while also keeping a track of sessions completed by
employees, as well as certifications achieved (if any). It performs activities
such as organizing sessions, managing certification, assigning curriculums
and modules, storing results, and much more. As a result, the workload is
reduced, gaps and areas for improvement are identified, and employee
productivity is increased.
18.
19. DOCUMENT MANAGEMENT
This feature of the QMS system helps in managing business-
critical documents. Manufacturers can store, create, track,
retrieve, and manage all types of organizational documents
through their life cycle. They can also maintain the audit
trails of viewed documents. These documents can be
secured using e-signature, passwords, etc.
20. COMPLAIN MANAGEMENT
Customer satisfaction is what all businesses aspire for.
Continuously providing high-quality products and services is
the best way for businesses to keep customers pleased.
Compliant management is a feature of the QMS system that
allows you to efficiently and effectively register, manage,
track, handle, and close client complaints. It has a simple
workflow and extensive reporting capabilities, that keep you
responsive and help meet their queries and complaints more
quickly and efficiently.
21. TYPES OF CUSTOMER COMPLAINS
Critical : Complaints related to defective/ dangerous/ Potentially life- threatening
medicines that predictably or probably could result in to serious health Risk /adverse
events or even death.
For Example (But not limited to): Wrong Product (Label and contents are different),
Correct product but wrong strength, with serious medical consequences, Wrong active
ingredient in a multi-component product, Mix-ups of some products.
Major : Complaints that could cause illness or mistreatment, but are not critical. For
example (but not limited to): Mislabelling (Wrong or missing text or figures) Missing or
incorrect information (leaflets or inserts) Chemical /Physical contamination Non-
Compliance with specification
Minor: Complaint which may not pose a significant hazard to health, complaints due to
secondary packing materials, Shortage complaints, Damage of containers.
22. PRODUCT RECALL
A recall is defined as the Company's removal of a marketed
product because of design or production defects that may
compromise safety, efficacy and purity of the product or
because of government regulation. A recall of a marketed
product will be instituted when either the product is
suspected or proven to be defective based on stability study,
market complaints, assessment of likelihood occurrence of
the hazard or if directed by the Food and Drugs
Administration or any Drug Control Authority or health /
regulatory authorities (RA) of the country where the product
is marketed.
23. TYPES OF RECALLS
Class I : This is for dangerous or defective products that cause serious
consequences to health including death. The decision to make an
urgent recall will be taken by the committee on the advice of the
medical adviser. The recall is initiated within 3 working days from
received date.
Class II : Such recalls are executed for products, which are found to be
defective or substandard, but which do not pose a health risk or might
cause a temporary health problem. The recall is initiated within 7
working days from received date.
Class III : These are recalls for products that are unlikely to cause any
adverse health reaction but that violate FDA labeling or manufacturing
regulations.
24. ANNUAL PRODUCT QUALITY REVIEW
• APQR prepared in pharmaceutical to review the consistency of the
products annually regarding their quality including the deviations, change
controls and market complaints. It is used as an effective product quality
improvement.
• Annual Product Review verifies the consistency of the existing
manufacturing process. It also helps to determine the quality and process
defects of the products. It determines the defects and possible
improvements to the method and process. The trend of the yield, analytical
results, manufacturing parameters of the products are also highlighted.
25. ANNUAL PRODUCT QUALITY REVIEW
• It reviews the quality of raw material and packing material used for the
product. The trend of these materials indicates the quality of the material
and the supplier also. In-process and the finished product results are
reviewed to determine the consistency of the product quality.
• The quantity of the final product is reviewed by the trending the yield of
every batch. Out of specification helps to determine the process defects
during the production of the specific product. Failure of the batch is also
included in APQR to determine the batch rejection of the product. Stability
study and its trend help to determine the defects regarding the product
stability.
26. ANNUAL PRODUCT QUALITY REVIEW
• APQR helps to determine the need for re-validation of the process and
effect of any improvement made previously. Corrective and preventive
actions and their impact on product quality are also reviewed and
determined.
• Annual Product Quality Review is a mandatory requirement of Good
Manufacturing Practice. FDA uses the term “Annual Product Review”
(APR) while “Product Quality Review” (PQR) term is used in EU-GMP
guidelines.
• According to 21 CFR 211.180 (e) all finished products should review
annually for the quality standards to determine the need for the change in
specification or manufacturing of drug product. Market complaints and
product recalls should also be reviewed annually.
