When you are in healthcare, Then GMP is must. Regulatory philosophy for product Quality have been changed from "Quality by Testing QbT" to "Quality by Design QbD". Quality is to be built in product and that only can be done by GMP.
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Pharmaceutical Good Manufacturing Practices
1.
2. Good Manufacturing Practice Regulations
Establishes minimum GMP for methods to be used, and the
facilities or controls to be used for, the manufacture, processing,
packing or holding of a drug to assure that the drug is
Safe
With appropriate identity and strength
Meets quality and purity characteristics
3. cGMP: Current Trends
21st Century: Risk-Based Approach
Risk-based assessment
Up-to-date Science-based policies and standards
Integrated Systems approach
Quality / Facilities and Equipment / Materials / Production /
Packaging and Labeling / Laboratory Control
International cooperation
ICH: International Conference on Harmonization
4. cGMP: The Basics
Quality Control
Product meets specifications
Quality Assurance
Systems ensure control and consistency
Validation, validation, validation
Documentation
If it is not documented, it did not happen
5. cGMP: Raw Materials
Active ingredients
Excipients
Audit suppliers on regular basis
Before entering into contract, review regulatory history
Monitor regulatory compliance
Test incoming raw material
6. cGMP: Buildings and Facilities
Separate or defined areas as are necessary to
prevent contamination or mix-ups
Air filtration systems (HVAC) in production areas
Sanitation
7. cGMP: Production and Process Controls
Written production and process control procedures shall be
followed in manufacturing and shall be documented at the time
of performance.
Any deviation from these procedures shall be recorded and
explained or justified.
(“SOPs”)
8. cGMP: In Process Testing
Must have written procedures and testing of product
while being manufactured to assure batch uniformity and
integrity
Control procedures shall be established to monitor output
and to validate manufacturing processes that could cause
variability
9. To assure that a drug
product meets applicable
standards of identity,
strength, quality and
purity at the time of use, it
shall bear an expiration
date determined by
appropriate stability
testing described in
Section 211.166.
Expiration dates shall be
related to any storage
conditions stated on the
labeling, as determined by
stability studies described
in Section 211.166.
cGMP: Expiration Dating
10. Company must have written procedures designed to assure
that correct labels, labeling and packaging materials are
used for drug products; such written procedures shall be
followed.
Label mix ups have been a major reason for drug product
recalls.
cGMP: Packaging and Labeling Operations
11. Testing and release for distribution
For each batch of drug product, there shall be laboratory
determination of satisfactory conformance to final
specifications for the drug product, including the identity and
strength of each active ingredient prior to release.
There shall be appropriate laboratory testing, as necessary,
of each batch required to be free of objectionable
microorganisms.
cGMP: Laboratory Controls
12. A written testing program designed to assess stability
characteristics is required.
Stability testing results must be used in determining
storage conditions and expiration dates.
cGMP: Stability Testing
13. Production and control records shall be reviewed and approved
by the quality control unit to determine compliance with all
established, approved written procedures before a batch is
released or distributed.
Product Impact Assessment
Trend Analysis
Distributed Product
cGMP: Production Record Review
14. Any unexplained discrepancy or the failure of a batch or
any of its components to meet any of its specifications must
be investigated whether or not the batch has already been
distributed.
Investigate other batches of same drug product
Investigate other drug products that may have been
associated with the specific failure or discrepancy
Written record of investigation
cGMP: Deviation Investigations
15. Documenting the Investigation is Critical
Hypotheses should be scientifically based
Subject matter experts should be consulted throughout the
investigation, including the initial identification of hypotheses
Once a hypothesis is identified, it must be investigated
All hypotheses should be validated or invalidated
cGMP: Deviation Investigations (cont….)
16. Corrective and Preventative Action Program
As part of deviation investigations...
Root cause identification and definitive corrective actions
• Company Program / System should audit:
– Timeliness of corrective / preventative actions
– Effectiveness of actions
– Documentation
• Example:
– Environmental monitoring/Cleaning
cGMP: Deviation Investigations (cont….)
17. Corrective and Preventative Action Program (cont…)
After an FDA inspection...
Establish scientifically sound corrective and preventative actions
Realistic timeframes
Ensure compliance with commitments to FDA
• Systems
• Specific Issues
E.g., Change Control / Training
cGMP: Deviation Investigations (cont….)
18. Quality control unit “shall have the responsibility and authority to
approve or reject all components, drug product containers,
closures, in-process materials, packaging material, labeling, and
drug products, and the authority to review production records to
assure that no errors have occurred or, if errors have occurred,
that they have been fully investigated.
The quality control unit shall be responsible for approving or
rejecting drug products manufactured, processed, packed, or held
under contract by another company.”
cGMP: Responsibility and Authority of
Quality Control
19. Written procedures describing the handling of all
written and oral complaints
Review by Quality Control unit
Possible failure to meet any specification
Determine need for deviation investigation
Adverse Drug Experience report assessment
Documentation of complaint and investigation or
reason for not investigating
cGMP: Complaints
20. Contemporaneous documentation critical
Laboratory and production records
Trending analysis
Data Integrity
Internal review : OOS results, complaints, R&D
External review: FDA inspections, business deals (due
diligence), and products liability cases
cGMP: Records and Reports
21. Field Alert Reports
Labeling
Failure to meet specifications — STABILITY FAILURES
Within 3 working days of receipt
Warner Lambert criminal case
Adverse Drug Experience Reports
ASAP but no later than 15 calendar days of initial receipt
Foreign and domestic
Recall Procedures and Preparation
cGMP: Reports (cont….)
22. Independent Audit Group
Resources
Authority
Global Approach - Harmonization of Quality Standards
Audit priority systems / specific issues
Follow-up audits
cGMP: Auditing
23.
24. Get the facility design right from the start
Validate processes
Write good Procedures and follow
Identify who does what
Keep good records
Train and develop staff
Practice good hygiene
Maintain facilities and equipment
Design quality into the whole product life cycle
Perform regular audits
Golden Rules of GMP
25.
26.
27. QC: Quality control; separation of production and quality
control (test of a single item)
QA: Quality assurance; introduction of a statistical approach
to quality control, a broader quality approach
QM: Quality management; understanding quality as a general
approach, with involvement of (nearly) all parts of a company
TQM: Total quality management; broadest quality approach,
integrates all parts of a company, including safety,
environmental protection …
Understanding ‘quality in the 20th century (2/2)
28. The manufacturer shall establish and implement an
effective pharmaceutical quality assurance system,
involving the active participation of the management
and personnel of the different services involved.
29. You must have a system.
The system must be GMP compliant (pharmaceuticals !).
Use the tools and the methodology of ISO and TQM to add to
your GMP system in order to gain the utmost benefit !
A well designed and maintained QA system will allow you
to relax … from time to time.
ISO or GMP ?
30. ISO describes a system approach
But fails to set standards (ISO lets the organisation set its own
levels)
GMP has required national standards
But lacks a system approach
TQM is a management approach
To long term success centered on “quality” through customer
satisfaction
TQM is based on the participation of all members of an
organisation in continually improving processes, products and
services
ISO, GMP and TQM
36. Business
• Establish if the company is
manufacturer or wholesaler;
• Assess the size of business in
terms of staff. Capital value,
Sales turnover. etc.
Manufacturing
• Ensure GMP compliance
• WHO Certification can be
used;
• Crosscheck with QA
system description
Quality
• Evaluate QA System:
• GMP requires companies to
have QC laboratories
Product
• Formulate decision from
regulatory status of a product
with well- established DRS;
• WHO Certification Scheme;
- Therapeutic equivalence
37. Pre analytical Analytical Post analytical
Right specimen
Laboratory
professionals
Recording
Right collection Reagents Interpretation
Right labeling Equipment Turnaround time
Right quantity Selection of test - SOP Report to right user
Right transport Records
Right storage Bio-Safety
Factors influencing Quality
38. There shall be a quality control unit that shall have the
responsibility and authority to approve or reject all components,
drug product containers, closures, in-process materials,
packaging material, labelling, and drug products, and the
authority to review production records to assure that no errors
have occurred or, if errors have occurred, that they have been
fully investigated.
The quality control unit shall be responsible for approving or
rejecting drug products manufactured, processed, packed, or
held under contract by another company.
FDA Requirements
39. Unrealistic Commitments
Process Execution
Poorly Executed Unit Processes
Inadequate Development Work
Process Development
Inadequate Batch Records
Process Validation
Data Integrity
Supply Chain
Facilities
Quality System
Challanges
40. The paradigms are changing, the focus
is shifting and changes are inevitable
41. Quality Assurance Quality Control
Definition
QA is a set of activities for
ensuring quality in the
processes by which products are
developed.
QC is a set of activities for ensuring
quality in products. The activities
focus on identifying defects in the
actual products produced.
Focus on
QA aims to prevent defects with
a focus on the process used to
make the product. It is a
proactive quality process.
QC aims to identify (and correct)
defects in the finished product.
Quality control, therefore, is a
reactive process.
Goal
The goal of QA is to improve
development and test processes
so that defects do not arise when
the product is being developed.
The goal of QC is to identify defects
after a product is developed and
before it's released.
Statistical
Techniques
Statistical Tools & Techniques
can be applied in both QA &
QC. When they are applied to
processes (process inputs &
operational parameters), they
are called Statistical Process
Control (SPC); & it becomes the
part of QA.
When statistical tools & techniques
are applied to finished products
(process outputs), they are called as
Statistical Quality Control (SQC) &
comes under QC.
42. What
Prevention of quality problems
through planned and
systematic activities including
documentation.
The activities or techniques used to
achieve and maintain the product
quality, process and service.
How
Establish a good quality
management system and the
assessment of its adequacy &
conformance audit of the
operation system & the review
of the system itself.
Finding & eliminating sources of
quality problems through tools &
equipment so that customer's
requirements are continually met.
Example
Verification is an example of
QA
Validation/Software Testing is an
example of QC
Responsibility
Everyone on the team involved
in developing the product is
responsible for quality
assurance.
Quality control is usually the
responsibility of a specific team that
tests the product for defects.
43. “Quality is never an accident;
it is always the result of intelligent effort.”
- John Ruskin
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