GMP

Good Manufacturing
Practice (GMP)
Presented by
Sheikh Mohammad Jobair Hossain

Head of Quality Assurance
National Drug Co. Ltd.
Definition
GMP is the part of Quality Assurance which ensures
that the products are consistently manufactured and
controlled to the Quality standards appropriate to
their intended use.
“GMP”- A set of principles and procedures which,
when followed by manufacturers for therapeutic
goods, helps ensure that the products manufactured
will have the required quality.
cGMP- Usually c= current, to emphasize that the
expectations are dynamic.
Quality: Quality of a medicinal product is measured
by its fitness for purpose. Safety and efficacy are not
separable from Quality but are part of it.
Good Manufacturing Practices
• A basic tenet of GMP is that quality cannot be tested into

a batch of product but must be built into each batch of
product during all stages of the manufacturing process.
• It is designed to minimize the risks involved in any

pharmaceutical production that cannot be eliminated
through testing the final product.
Why GMP is Important?
• A poor quality medicine may contain toxic substances that have been
unintentionally added.
• A medicine that contains little or none of the claimed ingredient will

not have the intended therapeutic effect.
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
• Has the appropriate identity and strength
• Meets quality and purity characteristics
cGMP Violations --
Severe Consequences
Product is “adulterated”
Shutdown of manufacturing facility
Seizure of product
Recall product
Front page press coverage
Competitive disadvantage
Severe Consequences (cont.)
GMP Hold on product applications

• International sites
Injunction / Consent decree

• Schering Plough ($500 Million)
• Abbott Laboratories ($100 Million)
• Wyeth–Ayerst Laboratories ($30 Million)
• Individual Defendants
Criminal Investigations and Indictments

Lawsuits
• United States ex rel. King
cGMP: The Basics
• Quality Control
• Product meets specifications
• Quality Assurance
• Systems ensure control and consistency
• Validation
• Documentation
• If it is not documented, it did not happen
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

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
cGMP: Production and Process
Controls (“SOPs”)
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.
cGMP: In Process Testing
• Musthave written procedures and testing of

product while being manufactured to assure
batch uniformity and integrity
• Controlprocedures shall be established to

monitor output and to validate manufacturing
processes that could cause variability
cGMP: Expiration Dating
• To assure that a drug

• Expiration dates shall
product meets be related to any
applicable standards of storage conditions
identity, strength, stated on the labeling,
quality, and purity at as determined by
the time of use, it shall stability studies.
bear an expiration date
determined by
appropriate stability
testing.
cGMP: Packaging and Labeling
Operations
• 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: Laboratory Controls
• 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: Stability Testing
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: Production Record
Review
• 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: Deviation
Investigations
• 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
(cont.)
 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
(cont.)
 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
(cont.)
 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: Responsibility and
Authority of Quality Control
• 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: Complaints
• 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: Records and Reports
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: Reports (cont.)
• Field Alert Reports § 314.81(b)(1)
• Labeling
• Failure to meet specifications — STABILITY FAILURES
• Within 3 working days of receipt
• Warner Lambert criminal case
• Adverse Drug Experience Reports § 314.80

• ASAP but no later than 15 calendar days of initial
receipt
• Foreign and domestic
• Recall Procedures and Preparation

cGMP: Auditing
• Independent Audit Group

• Resources
• Authority
• Global Approach - Harmonization of Quality

Standards
• Audit priority systems / specific issues
• Follow-up audits
Any Questions?

GMP

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Good Manufacturing

Sheikh Mohammad Jobair Hossain

• A basic tenet of GMP is that quality cannot be tested into

• It is designed to minimize the risks involved in any

• A medicine that contains little or none of the claimed ingredient will

• Establishes minimum GMP for methods

Shutdown of manufacturing facility

Front page press coverage

GMP Hold on product applications

Injunction / Consent decree

Criminal Investigations and Indictments

• Monitor regulatory compliance

• Test incoming raw material

• Separate or defined areas as are

Written production and process control

• Musthave written procedures and testing of

• Controlprocedures shall be established to

• To assure that a drug

• Company must have written procedures

• There shall be appropriate laboratory testing, as

A written testing program designed to

• Product Impact Assessment

• Investigate other batches of same drug product

• Investigate other drug products that

• Written record of investigation

 Documenting the Investigation is Critical

• After an FDA inspection...

• Written procedures describing the

• Documentation of complaint and

• Adverse Drug Experience Reports § 314.80

• Recall Procedures and Preparation

• Independent Audit Group

• Global Approach - Harmonization of Quality

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