I am uploading this GMP presentation to make aware who are working in pharma and help to maintain high standards in products manufacturing . GMP Vs cGMP: 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. FDA (Food and Drug Administration) included the word “current” to ensure that regulated firms use the most current Good Manufacturing Practices (I believe that some firms would actually use outdated versions of the GMP’s to manufacture regulated products. (the FDA have made their standards immediately identifiable i.e cGMP; Other international bodies such as the ICH, WHO use the term GMP, as do Canada, Japan and the EMEA (European authority). In FDA view cGMP means following 21 CFR 210 and 211 and no other.)

1. Good Manufacturing Practice
Guidelines
ICH Q7A
Presented by
Malangsha S

2. Obj ect i ve of
• To produce products conforming to
predetermined specification
• To produce Product of consistent
quality
• To minimize contamination

4. Regul at or y Agenci es |
International Conference on
Harmonization. This consist of EU, US
and Japan.
The United States
Food and Drug Administration
European Directorate of Quality
Medicines

5. I CH Modul es
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

6. Principles
Quality should be the responsibility of all persons involved in
manufacturing.
Responsibilities of the Quality Unit(s)
involved in all quality-related matters.
review and approve
Establishing a system to release packaging and labeling
materials
Performing product quality reviews
Internal Audits (Self Inspection)
Regular internal audits should be performed in accordance
with an approved schedule.
Document audit findings and corrective actions
Agreed corrective actions should be completed in a timely
and effective manner.

7. Responsibility for Production Activities
The responsibility for production activities should be
described in writing
All deviations are reported and critical deviations are
investigated and the conclusions recorded
production facilities are clean and when appropriate
disinfected
the necessary calibrations are performed and records kept
validation protocols and reports are reviewed and approved
new and, when appropriate, modified facilities and equipment
are qualified.
Product Quality Review
Regular quality reviews of APIs should be conducted with the
objective of verifying the consistency of the process.

8. Personnel Qualifications
There should be an adequate number of personnel
qualified by appropriate education, training and/or
experience to perform and supervise the manufacture
of intermediates and APIs.
Personnel Hygiene
should practice good sanitation and health habits.
should avoid direct contact with intermediates or APIs.
Personnel suffering from an infectious disease or having
open lesions on the exposed surface of the body should not
engage in activities that could result in compromising the
quality of APIs.
Consultants
Consultants should have sufficient education, training, and
experience, or any combination thereof, to advise on the
subject

9. Buildings and facilities should be:
Located, Designed, and Constructed to facilitate
cleaning, maintenance, and operations as appropriate to
the type and stage of manufacture
minimize potential contamination.
designed to limit exposure to objectionable
microbiological contaminants
Utilities should be:
Qualified and appropriately monitored
action should be taken when limits are exceeded..
Drawings for these utility systems should be available
Water should be:
Water used in the manufacture of APIs should be
demonstrated to be suitable for its intended use.

10. Containment
Dedicated production areas, air handling equipment
and/or process equipment, should be employed in the
production of highly sensitizing materials, such as
penicillins or cephalosporins.
Lighting should be:
Adequate lighting should be provided in all areas to
facilitate cleaning, maintenance, and proper operations.
Sewage should be:
disposed of in a safe, timely, and sanitary manner.
Containers and/or pipes for waste material should be
clearly identified.
Sanitation and Maintenance:
Buildings should be properly maintained and repaired and
kept in a clean condition and establish written procedures

11. Design and Construction
Equipment should be of appropriate design and adequate
size, and suitably located for its intended use
Equipment Maintenance and Cleaning
preventative maintenance of equipment.
Written procedures should be established
Cleaning procedures should contain sufficient details to
clean each type of equipment in a reproducible and
effective manner
Equipment should be identified as to its contents and its
cleanliness status
Acceptance criteria should be defined and justified.

12. Calibration
Control, weighing, measuring, monitoring and test equipment
that is critical for assuring the quality of intermediates or APIs
should be calibrated according to written procedures and an
established schedule.
Computerized Systems
GMP related computerized systems should be validated
installation qualification and operational qualification
should demonstrate the suitability to perform assigned
Ctaosmkpsuterized systems should have sufficient controls to prevent
unauthorized access or changes to data.
Changes to the computerized system should be made
according to a change procedure
If system breakdowns or failures would result in the
permanent loss of records, a back-up system should be
provided.

13. Documentation System and Specifications
All documents related to the manufacture of intermediates or
APIs should be prepared, reviewed, approved and distributed
according to written procedures. Such documents can be in
paper or electronic form.
Equipment Cleaning and Use Record
Records of major equipment use, cleaning, sanitization
and/or sterilization and maintenance should show the date,
time (if appropriate), product, and batch number of each
batch processed in the equipment, and the person who
performed the cleaning and maintenance.
Raw Material Records
Records should be maintained including: name, identity,
quantity; name of the supplier; supplier's control number(s),
the number allocated on receipt & date of receipt;
Master (approved) labels should be maintained for
comparison to issued labels.

14. Master Production and Control Records)
To ensure uniformity from batch to batch, master production
instructions for each intermediate and API should be prepared,
dated, and signed by one person and independently checked,
dated, and signed by a person in the quality unit(s).
Batch Production and Control Records)
Batch production records should include complete
information relating to the production and control of each
batch.
These records should be numbered with a unique batch or
identification number, dated and signed when issued.
Documentation of completion of each significant step in the
batch production
Laboratory Control Records
Laboratory control records should include complete data
derived from all tests conducted to ensure compliance with
established specifications and standards, including
examinations and assays,

15. General Controls
There should be written procedures describing the receipt,
identification, quarantine, storage, handling, sampling, testing,
and approval or rejection of materials.
should have a system for evaluating the suppliers of critical
materials.
Changing the source of supply of critical raw materials
should be treated according to Change Control.
Receipt and Quarantine
each container or grouping of containers of materials should
be examined visually
Materials should be held under quarantine until they have
been sampled, examined or tested as appropriate, and
released for use.
Each container or grouping of containers (batches) of
materials should be assigned and identified with a
distinctive code, batch, or receipt number.

16. Sampling and Testing
Sampling should be conducted at defined locations
Containers from which samples are withdrawn should be marked
to indicate that a sample has been taken.
At least one test to verify the identity of each batch of material
should be conducted,
A supplier's Certificate of Analysis can be used in place of
performing other tests
Storage
Materials should be handled and stored in a manner to
prevent degradation, contamination, and cross-contamination.
Rejected materials should be identified and controlled under
a quarantine system
Re-evaluation
Materials should be re-evaluated as appropriate to
determine their suitability for use

17. Production Operations
Raw materials for intermediate and API manufacturing should be
weighed or measured under appropriate conditions that do not
affect their suitability for use.
The processing status of major units of equipment should be
indicated either on the individual units of equipment
Materials to be reprocessed or reworked should be appropriately
controlled to prevent unauthorized use.
Time Limits
time limits should be met to ensure the quality of
intermediates and APIs
Intermediates held for further processing should be stored
under appropriate conditions to ensure their suitability for
use.
In-process Sampling and Controls
Written procedures should be established to monitor the
progress and control the performance of processing

18. Production Operations
Raw materials for intermediate and API manufacturing should be
weighed or measured under appropriate conditions that do not
affect their suitability for use.
The processing status of major units of equipment should be
indicated either on the individual units of equipment
Materials to be reprocessed or reworked should be appropriately
controlled to prevent unauthorized use.
Time Limits
time limits should be met to ensure the quality of
intermediates and APIs
Intermediates held for further processing should be stored
under appropriate conditions to ensure their suitability for
use.
In-process Sampling and Controls
Written procedures should be established to monitor the
progress and control the performance of processing

19. Blending Batches
Blending is defined as the process of combining materials within
the same specification to produce a homogeneous intermediate
or API.
Blending processes should be adequately controlled, tested for
conformance and documented
The batch record of the blending process should allow
traceability back to the individual batches that make up the
blend.
Contamination Control
Residual materials can be carried over into successive
batches of the same intermediate or API if there is adequate
control.
Precautions to avoid and prevent contamination

20. General
Packaging and labelling materials should conform to established
specifications.
Records should be maintained for each shipment of labels and
packaging materials
Packaging Materials
Containers should be clean, provide adequate protection
against deterioration or contamination
If containers are re-used, they should be cleaned in
accordance with documented procedures
Label Issuance and Control
Access to the label storage areas should be limited to
authorised personnel.
Obsolete and out-dated labels should be destroyed.

21. Packaging and Labelling Operations
Labels used on containers of intermediates or APIs should
indicate the name or identifying code, the batch number of the
product, and storage conditions, when such information is
critical to assure the quality of intermediate or API.
For intermediates or APIs with a retest date, the retest date
should be indicated on the label and/or Certificate of
Analysis.

22. Warehousing Procedures
Facilities should be available for the storage of all materials
under appropriate conditions
separate storage areas should be assigned for their temporary
storage until the decision as to their future use has been taken.
Distribution Procedures
APIs and intermediates should only be released for
distribution to third parties after they have been released
by the quality unit(s).
transported in a manner that does not adversely affect their
quality.
Special transport or storage conditions for an API or
intermediate should be stated on the label.
A system should be in place by which the distribution can be
readily determined to permit its recall.

23. General Controls
adequate laboratory facilities.
documented procedures describing sampling, testing, approval
or rejection of materials
Any out-of-specification result obtained should be
investigated and documented according to a procedure
primary reference standard & Secondary reference standards,
reagents and standard solutions
Testing of Intermediates and APIs
An impurity profile describing the identified and unidentified
impurities present should normally be established for each API.
Appropriate microbiological tests should be conducted on each
batch

24. Validation of Analytical Procedures
Certificates of Analysis
Authentic Certificates of Analysis should be issued for each batch
The Certificate should list each test performed in accordance
with compendial or customer requirements, including the
acceptance limits, and the numerical results obtained (if test
results are numerical).
Stability Monitoring of APIs
A documented, on-going testing program should be designed to
monitor the stability characteristics of APIs,
Expiry and Retest Dating
API expiry or retest date should be based on an evaluation of
data derived from stability studies.
Reserve/Retention Samples

25. Validation Policy
The company's overall policy, intentions, and approach to
validation,
The critical parameters/attributes should normally be identified
during the development stage or from historical data,
Validation Documentation
A written validation protocol should specify critical process steps
and acceptance criteria as well as the type of validation to be
conducted
A validation report cross-referencing the validation protocol
summarising the results obtained, commenting on any
deviations observed, should be prepared
Qualification
Before starting process validation activities, appropriate qualification
of critical equipment and ancillary systems should be completed.
Design Qualification (DQ), Installation Qualification (IQ), Operational
Qualification (OQ) & Performance Qualification (PQ)

26. Approaches to Process Validation
There are three approaches to validation.
Process Validation (PV), Prospective validation & Concurrent
validation
retrospective validation
Process Validation Program
The number of process runs
Critical process parameters
Process validation should confirm that the impurity profile for
each API is within the limits specified.
Periodic Review of Validated Systems
Systems and processes should be periodically evaluated to verify
that they are still operating in a valid manner.

27. Cleaning Validation
In general, cleaning validation should be directed to situations
or process steps where contamination or carryover of materials
poses the greatest risk to API quality.
Validation of cleaning procedures should reflect actual
equipment usage patterns
cleaning validation protocol
Sampling should include swabbing, rinsing, or alternative
methods
Validation of Analytical Methods
Analytical methods should be validated unless the method
employed is included in the relevant pharmacopoeia or other
recognised standard reference.
Appropriate qualification of analytical equipment

28. CHANGE CONTROL
change control system
Any proposals for GMP relevant changes should be drafted,
reviewed, and approved
Evaluate potential impact of the proposed change on the quality
When implementing approved changes, measures should be
taken to ensure that all documents affected by the changes are
revised.

29. REJECTION
Intermediates and APIs failing to meet established specifications
should be identified as such and quarantined. The final
disposition of rejected materials should be recorded.
REPROCESSING
Introducing back into the process and reprocessing by repeating
a crystallization step or other appropriate chemical or physical
manipulation steps is generally considered acceptable.
REWORKING
Before a decision is taken to rework batches that do not conform
to established standards or specifications, an investigation into
the reason for non-conformance should be performed.

30. All quality related complaints, whether received orally or in
writing, should be recorded and investigated according to a
written procedure.
There should be a written procedure that defines the
circumstances under which a recall of an intermediate or API
should be considered.
The recall procedure should designate who should be involved in
evaluating the information, how a recall should be initiated, who
should be informed about the recall, and how the recalled
material should be treated.

31. Recovery of Materials and Solvents
Solvents can be recovered and reused in the same processes or
in different processes,
Fresh and recovered solvents and reagents can be combined if
adequate testing has shown
Solvents can be recovered and reused in the same processes or
in different processes,
Returns
Returned intermediates or APIs should be identified as such and
quarantined.
Records of returned intermediates or APIs should be maintained.
If the conditions under which returned intermediates or APIs
have been stored casts doubt on their quality, the returned
intermediates or APIs should be reprocessed, reworked, or
destroyed, as appropriate.