GMP and cGMP
Considerations
Dr. Nadia Anwar
Lecturer
UBAS
Content
What is GMP
What is cGMP
Main risks
Why GMP is important
Export opportunities
Ten Principles of GMP
Cost of effective GMP
List of important documents in GMP
Attributes of a good document
ICH Modules
What is GMP?
GMP is that 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.
What is
cGMP?
Usually see
“cGMP” –
where c =
current, to
emphasize
that the
expectations
are dynamic
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.
Some of the main risks are
unexpected contamination of products, causing
damage to health or even death.
incorrect labels on containers, which could
mean that patients receive the wrong medicine.
insufficient or too much active ingredient,
resulting in ineffective treatment or adverse
effects.
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.
GMP helps boost pharmaceutical
export opportunities
Most countries will only accept import and sale
of medicines that have been manufactured to
internationally recognized GMP.
Governments seeking to promote their
countries export of pharmaceuticals can do so
by making GMP mandatory for all
pharmaceutical production and by training their
inspectors in GMP requirements.
GMP Covers
ALL aspects of production; from the starting
materials, premises and equipment to the
training and personal hygiene of staff.
Detailed, written procedures are essential for
each process that could affect the quality of the
finished product.
There must be systems to provide documented
proof that correct procedures are consistently
followed at each step in the manufacturing
process - every time a product is made.
Ten Principles of GMP
Design and construct the facilities and equipments
properly
Follow written procedures and Instructions
Document work
Validate work
Monitor facilities and equipment
Write step by step operating procedures and work
on instructions
Design ,develop and demonstrate job competence
Protect against contamination
Control components and product related processes
Conduct planned and periodic audits
Cost of effective GMP
In fact Cost benefits – positive cost benefits of
GMP/QA
Good plant lay out, Smooth work flows, Efficient
documentation systems, well controlled process,
good stores lay outs and stores records- These
are Good manufacturing practices
Avoidance of cost of Quality failure (cost of
waste, of rework, of recall, of consumer
compensation and of loss of company
reputation)
List of important documents in
GMP
Policies
SOP
Specifications
MFR (Master Formula Record)
Manuals
Master plans/ files
Validation protocols
Forms and Formats
Records
10 attributes of a good
document
Accurate
Clear
Complete
Consistent
Indelible
Legible
Timely
Direct
Authentic
Authorized
Production of API
Tablet Production
Sterile Production
Certifying agencies
ICH. [Link]
WHO. [Link]
US FDA. [Link]
EU/EMEA. [Link]
How do GMPs of different
countries
compare?
At a high level, GMPs of various nations are very
similar; most require things like:
Equipment and facilities being properly
designed, maintained, and cleaned
Standard Operating Procedures (SOPs) be
written and approved
An independent Quality unit (like Quality
Control and/or Quality Assurance)
Well trained personnel and management
What are cGMPs?
cGMP refers to the Current Good Manufacturing
Practice regulations enforced by the US Food
and Drug Administration (FDA).
cGMP provide for systems that assure proper
design, monitoring and control of
manufacturing processes and facilities.
Adherence to the cGMP regulations assures the
identity, strength, quality and purity of drug
products by requiring that manufacturers of
medications adequately control manufacturing
operations
cGMP Includes
Organization & Personnel
Building & Facilities
Equipment
Control of Components & Drug
Product Containers & Closures
Production & Process Control
Packaging & Labeling Control
Handling & Distribution
Laboratory Control
Records & Reports
Returned & Salvaged Drugs
Why are cGMP so important
A consumer usually cannot detect (through
smell, touch, or sight) that a drug product is
safe or if it will work.
While cGMPs require testing, testing alone is not
adequate to ensure quality.
In most instances testing is done on a small
sample of a batch (for example, a drug
manufacturer may test 1000 tablets from a
batch that contains 2 million tablets), so that
most of the batch can be used for patients
rather than destroyed by testing.
cGMP Vs GMP
It is my understanding that , Ultimately GMP &
cGMP both the aim is same, means to
prevention of the product from bad quality
entering the market to endover peoples's life.
GMP applies to pharmaceutical and healthcare
products and help to maintain high standards in
these products.
cGMP is to remind accepting countries that all
guidelines must be followed with latest and
current production processes i.e employ
technologies and systems which are up-to-date
in order to comply with the regulation.
ICH Modules
Q1 - Stability testing
Q2 – Validation of Analytical Procedures
Q3 – Impurities
Q4 – Evaluation – Pharmacopoeia Texts
Q5 – Biotechnology Products
Q6 – Specifications
Q7 – Good Manufacturing Practices
Q8 – Pharmaceutical Development
Q9 – Quality Risk Management
Q10 – Pharmaceutical Quality System
