The document provides an overview of the ICH Q7 guidelines focused on Good Manufacturing Practice (GMP) for active pharmaceutical ingredients (APIs), emphasizing the importance of quality assurance and control in drug manufacturing. It outlines the responsibilities of personnel, facility requirements, production processes, and documentation necessary to ensure high-quality and effective medicines. Adhering to these guidelines is essential for regulatory compliance and improving manufacturing efficiency.

1. ICH GMP GUIDELINES Q7
BY-
PROF. VEDANSHU MALVIYA
P.R. POTE PATIL COLLAGE OF PHARMACY,
AMARAVATI.

2. Content
> Introduction
> Members of ICH
> Purpose of ICH
> I
CH guidelines
> I
CH Q7 guideline GMP for API
> Conclusion
> References

3. Introduction
> The complete name of ICH is the "International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human use.
> ICH Established in 1990 between the European Union, Japan, and united
states.
> Committed to reducing duplication during research and development of
new drugs while safeguarding quality, safety and efficacy.

4. Purpose of ICH
> Safe, effective and high quality medicines are developed and registered in
the most efficient and cost effective manner.
> To Promote public health.
> Prevent unnecessary duplication of clinical test.
> Minimize the use of animal testing without compromising safety and
effectiveness.
> Identification elimination of the need to duplicate studies to meet different
regulatory requirements.

5. I
CH Guidelines
The ICH Topics are divided into four major categories and ICH Topic Codes
are assigned according to these categories.

6. I
CH Q7 Guidelines GMP for API
> GMP is that part of Quality assurance, which ensure that products are
consistently produce and controlled to the quality standards appropriate to
their intended use and as required by the marketing authorization.
> This document (Guide) is intended to provide guidance regarding good
manufacturing practice (GMP) for the manufacturing of active
pharmaceutical ingredients (APIs) under an appropriate system for
managing quality.
> Inthis Guide "manufacturing" is defined to include all operations of receipt
of materials, production, packaging, repackaging, labelling, relabeling,
quality control, release, storage and distribution of APIsand the related
controls.

7. Quality Management
> Quality should be the responsibility of all persons involved in manufacturing.
> There should be a quality unit(s) that is independent of production and that
fulfills both quality assurance and quality control responsibilities.
QC UNI
T:
• The quality unit(s) should be involved in all quality-related matters.
• Releasing or rejecting all APIs. Releasing or rejecting intermediates for use
outside the control of the manufacturing company.
• Establishing a system to release or reject raw materials, intermediates,
packaging, and labeling materials.

8. Cont…
> QA Unit –
1. Review & approve all quality related documents.
2. Review of batch production & quality control records.
3. Making sure that the premises and equipment are maintained and records kept.
4. Reviewing & Approving validation protocols.
5. Making sure that production facilities are clean and, when appropriate,
disinfected.
> I
nternal Audits (Self I
nspection) –
To verify compliance with the principles of GMP for APIs, regular internal audits should be
performed in accordance with an approved schedule.
> Product Quality Review –
A review of adequacy of corrective actions.
A review of any changes carried out to the processes or analytical methods;
A review of all batches that failed to meet established specification(s).

9. Personnel
> Personnel Qualifications
> Responsibilities
> Personnel Hygiene –
1. Personnel should practice good sanitation and health habits.
2. Personnel should avoid direct contact with intermediates or APIs.
3. Smoking, eating, drinking, chewing and the storage of food should be restricted

10. Buildings & Facilities
> Design & Construction
o Buildings & facilities should have adequate space for the orderly placement of
equipment & material top prevent mix ups & contamination.
o There should be defined areas or other control systems for the following
activities:
1. Receipt, identification, sampling, and quarantine of incoming materials, pending
release or rejection;
2. Storage of released materials.
3. Production operations.
4. Packaging and labelling operations.
5. Laboratory operations.

11. > Utilities
> All utilities that could impact on product quality (e.g. steam, gases, compressed
air, and heating, ventilation and air conditioning)
> Water
> Water used in the manufacture of APIs should be demonstrated to be suitable for
its intended use.
> Where water used in the process is treated by the manufacturer to achieve a
defined quality, the treatment process should be validated and monitored with
appropriate action limits.
> Containment
> Lighting
> Sewage & Refuse
> Sanitation & Maintenance

12. Process Equipment
> Design & Construction
1. Equipment used in the manufacture of intermediates and APIs should be of
appropriate design and adequate size, and suitably located for its intended use,
cleaning, sanitization (where appropriate), and maintenance.
2. Production equipment should only be used within its qualified operating range.
> Equipment Maintenance & Cleaning
1. Schedules and procedures (including assignment of responsibility)should be
established for the preventative maintenance of equipment.
2. Inspection of equipment for cleanliness immediately before use• Assignment of
responsibility for cleaning of equipment.
3. A complete description of the methods and materials, including dilution of cleaning
agents used to clean equipment.

13. > 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
> The depth and scope of validation depends on the diversity, complexity
and criticality of the computerized application.
> Appropriate installation qualification and operational qualification
should demonstrate the suitability of computer hardware and software
to perform assigned tasks.

14. Documentation & Records
> 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.
> All production, control, and distribution records should be retained for at least 1
year after the expiry date of the batch. For APIs with retest dates, records should
be retained for at least 3 years after the batch is completely distributed.

15. > 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.
> Records of Raw Materials, I
ntermediates, APILabelling and Packaging
Materials
> The name of the manufacturer, identity and quantity of each shipment of each
batch of raw materials, intermediates or labelling and packaging materials for
API's;the name of the supplier;the supplier's control number(s), if known, or other
identification number; the number allocated on receipt; and the date of receipt.

16. > Batch Production Records (Batch Productionand Control Records)
> Batch production records should be prepared for each intermediate and API and should
include complete information relating to the production and control of each batch.
> Batch production record should include,
> Name of API
> Batch No.
> Date
> Identity of majorequipment.
> Specific identification of each batch including weight, measures, & batch no. of raw
materials.
> Signature of the person performing &directly supervising the each critical steps in the
operation.

17. > Laboratory Control Records
> Description of samples received for testing which includes,
- Material name
- Batch No.
- Date of Sampling
- Quantity
- Date - the sample wasreceived for testing.
2) Reference to each test method.
3)Weight of sample used foreach test.
4)A complete record of all raw data generated during each test with graphs,
charts& spectra from laboratory instrumentation.
5)Signature of the person who performed each test & the date on which the
tests were performed.

18. Material Management
> General Controls: There should be written procedures describing the
receipt, identification, quarantine, storage, handling, sampling, testing and
approval or ejection of materials.
> Receipt and Quarantine: Upon receipt and before acceptance, each
container or grouping of containers of materials should be examined
visually.
> Sampling and Testing of Incoming Production Materials.
> Storage: Materials should be handled and stored in a manner to prevent
degradation, contamination, and cross-contamination.
> Re-evaluation: Materials should be re-evaluated as appropriate to
determine their suitability for use (e.g., after prolonged storage or exposure
to heat or humidity).

19. Production & In proccess Controls
> Production Operations
> Time Limits
> I-process Sampling and Controls
> Blending Batches of Intermediates or APls
> Contamination Control -Residual materials can be carried over into
successive batches of the same intermediate or API if there is adequate
control.

20. STORAGE AND DISTRIBUTION
> Warehousing Procedures - Facilities should be available for the storage of
all materials under appropriate conditions (e.g. controlled temperature
and humidity when necessary.
> Distribution Procedures -1)APIs and intermediates should only be released
for distribution to third parties after have been released by the quality unit.
2)APIs and intermediates should be transported in a manner that does not
adversely affect their quality.
3) Special transport or storage conditions for an API.

21. Conclusion
> ICH Q7 is very important in maintaining quality of the API.
> API manufacturer can improve output of the manufacturing process.
> Helps to enhance productivity as well as effectiveness of the manufacturing
process.
> ICH Q7 ensures less batch to batch variations and less chances of recalls.
> Following this guideline can also help during regulatory inspections.

22. References
> Good manufacturing practice guide for active pharmaceutical ingredients
Q7,current step 4 version dated 10 November 2000.
> Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical
I
ngredients Guidance for I
ndustry September 2016.
> Kuchekar B.S., Khadatare A.M., ItkarS.C., Forensic Pharmacy, Nirali
Publication, page no.16.16 to 16.25
> www.ich.org (official ICH Web site)

23. THANK YOU…….!