National Good Manufacturing Practice Code

2072
Definitions:
 Good Manufacturing Practice: GMP is a part of Quality Assurance which ensures the
Medicinal Products are consistently produced and controlled to the quality standards
appropriate to their intended use and as required by the marketing authorization or
product specification.

 Active pharmaceutical Ingredients(API): Any substance or mixture of substances

intended to be used in the manufacturing of a pharmaceutical dosage form and that ,
when so used, becomes an active ingridient of that pharmaceutical dosage form.

 Calibration The demonstration that a particular instrument or device produces results

within specified limits by comparison with those produced by a traceable standard over
an appropriate range of measurements. Limits for acceptance of the results of measuring
should be established.

 Clean area An area (room) with defined environmental control of particulate and
microbial contamination constructed and used in such a way as to reduce the
introduction, generation, and retention of contaminants within the area

 Actual Yield The quantity that is actually produced at any stage of production of a
particular product from a given amount of input material

 Airlock An enclosed space with two or more doors which is interposed between two or
more rooms, e.g., of differing classes of cleanliness, for the purpose of controlling the
airflow between those rooms when they need to be entered. An airlock is designed for use
either by people or for goods and/or equipment.

 Authorized person The person recognized by the Authority as having the responsibility
for ensuring that each batch of finished product has been manufactured, tested and
approved for release in compliance with the requirements of marketing authorization.

 Validation Master Plan VMP is a high-level document which establishes an umbrella

validation plan for the entire project, and is used as guidance by the project team for
resource and technical planning (also referred to as master qualification plan).

 Stndard operating System

 Consignment

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  Controlled Area –

 Cross-contamination

 Self-contained area

 Batch, Batch no

 Recovery , reprocessing and reworking

 Master formula

 Market Authorization

 Master record

 Quarantine

 Intermediate product , bulk product and finished product

 Large volume parenterals

 Starting material

Quality control
Quality Control is that part of Good Manufacturing Practice which is concerned with sampling,
specifications and testing, and with the organization, documentation and release procedures
which ensure that the necessary and relevant tests are actually carried out and that materials are
not released for use, nor products released for sale or supply, until their quality has been judged
to be satisfactory.

Basic Requirements of quality control

 Adequate facilities, trained personnel and approved procedures

 Samples of starting materials, packaging materials, intermediate products, bulk

products and finished products are taken by personnel and by methods approved
by Quality Control;

 Validated test methods

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  Records are made, manually and/or by recording instruments, which demonstrate
that all the required sampling, inspecting and testing procedures were actually
carried out. Any deviations are fully recorded and investigated;

 Sufficient reference samples of starting materials and products are retained to

permit future examination of the product if necessary and that the product is
retained in its final pack unless exceptionally large packs are produced.

Quality Assurance
Quality Assurance is a wide-ranging concept, which covers all matters, which individually or
collectively influence the quality of a product. It is the sum total of the organized arrangements
made with the objective of ensuring that medicinal products are of the quality required for their
intended use.

The system of Quality Assurance appropriate for the manufacture of medicinal products should
ensure that:

 Medicinal products are designed and developed in a way that takes account of the
requirements of Good Manufacturing Practice

 Production and control operations are clearly specified and Good Manufacturing Practice
adopted;

 Managerial responsibilities are clearly specified;

 Arrangements are made for the manufacture, supply and use of the correct starting and
packaging materials;

 All necessary controls on intermediate products, and any other in process controls and
validations are carried out

 The finished product is correctly processed and checked, according to the defined
procedures

 Satisfactory arrangements exist to ensure, as far as possible, that the medicinal products
are stored, distributed and subsequently handled so that quality is maintained throughout
their shelf life;

 There is a procedure for self-inspection and/or quality audit, which regularly appraises
the effectiveness and applicability of the quality assurance system.

GMP FOR PRODUCT

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Good Manufacturing Practice is concerned with both production and quality control. The basic
requirements of GMP are that

1. All manufacturing processes are clearly defined, systematically reviewed in the light of
experience and shown to be capable of consistently manufacturing medicinal products of the
required quality

2. Critical steps of manufacturing processes and significant changes to the process are validated;

3 All necessary facilities for GMP are provided including:

 i. appropriately qualified and trained personnel;

 ii. adequate premises and space;

 iii. suitable equipment and services;

 iv. correct materials, containers and labels;

 v. approved procedures and instructions;

4 Instructions and procedures are written in an instructional form in clear and unambiguous
language

5. Operators are trained to carry out procedures correctly.

6. A system is available to recall any batch of product, from sale or supply

7. Complaints about marketed products are examined, the causes of quality defects investigated
and appropriate measures taken in respect of the defective products and to prevent re-occurrence

SANITIZATION AND HYGIENE

 A high level of sanitation and hygiene should be practiced in every aspect of the
manufacture of pharmaceutical products.

 Potential sources of contamination should be eliminated through an integrated

comprehensive programmed of sanitation and hygiene.

General

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  The layout and design of premises must aim to minimize the risk of errors and permit
effective cleaning and maintenance in order to avoid cross-contamination, build-up of
dust or dirt, and, in general, any adverse effect on the quality of products.

 Where dust is generated (e.g. during sampling, weighing, mixing and processing
operations, packaging of powder), measures should be taken to avoid crosscontamination
and facilitate cleaning.

 High level of personal hygiene should be followed and observed by all those concerned
with manufacturing processes In particular, personnel should be instructed to wash their
hands before entering production areas. Signs to this effect should be posted and
instructions observed

 If a product defect is discovered or suspected in a batch, consideration should be given to

checking other batches in order to determine whether they are also affected.

 All the decisions and measures taken as a result of a complaint should be recorded and
referenced to the corresponding batch records.

 Complaints records should be reviewed regularly for any indication of specific or

recurring problems requiring attention and possibly the recall of marketed products

COMPLAINTS AND PRODUCT RECALL

Complaints

 There should be designated person responsible for handling the complaints and deciding
the measures to be taken together with sufficient supporting staff to assist him.

 There should be written procedures describing the action to be taken, including the need
to consider a recall, in the case of a complaint concerning a possible product defect.

 Any complaint concerning a product defect should be recorded with all the original
details and thoroughly investigated.

Recall

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  There should be designated person responsible for execution and co-ordination of recalls
and should be supported by sufficient staff to handle all the aspects of the recalls.

 There should be established written procedures, regularly checked and updated when
necessary, in order to organize any recall activity.

 The Authority should be informed promptly if products are intended to be recalled

because they are, or are suspected of, being defective.

 The distribution records should be readily available to the person(s) responsible for
recalls, and should contain sufficient information on wholesalers and directly supplied
customers.

 Recalled products should be identified and stored separately in a secure area while
awaiting a decision on their fate.

Self Inspection and Quality Audits

Items for self-inspection:

 Self-inspection team

 Frequency of self-inspection

 Self-inspection report

 Follow-up action

 Quality audit

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  Suppliers’ audits and approval

Personnel
General

 The manufacturer should have an adequate number of personnel with the necessary
qualifications and practical experience.

 The manufacturer must have an organization chart. People in responsible positions

should have specific duties recorded in written job descriptions and adequate authority to
carry out their responsibilities

• Responsibilitity
Check the maintenance of his department, premises and equipment
The authorisation of written procedures and other documents, including amendments
Monitoring and control of the manufacturing environment;
Planthygiene;Processvalidation; Training;

Training
 The manufacturer should provide training for all the personnel whose duties take them
into production areas or into control laboratories.

 Personnel working in areas where contamination is a hazard, e.g. clean areas or areas
where highly active, toxic, infectious or sensitising materials are handled, should be
given specific training.

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  Visitors or untrained personnel should, preferably, not be taken into the production and
Quality Control areas.

Personal Hygiene
 hygiene programmes should be established

 All personnel should receive medical examination

 Should wear protective garments appropriate to the operations to be carried out

 Eating, drinking, chewing or smoking, or the storage of food, drink, smoking materials or
personal medication in the production and storage areas should be prohibited

 Direct contact should be avoided between the operator's hands and the exposed product
as well as with any part of the equipment that comes into contact with the products

PREMISES

 General

 Ancillary areas

 Storage areas

 Weighing area

 Production areas

 Quality control area

Equipments
 Equipment must be located, designed, constructed, adapted and maintained to suit the
operations to be carried out.

 Their layout and design must aim to minimize the risk of errors and permit effective
cleaning and maintenance in order to avoid cross-contamination.

Materials
 No materials used for operations such as cleaning, lubrication of equipment and pest
control, should come into direct contact with the product.

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  All incoming materials and finished products should be quarantined immediately after
receipt or processing and inspection, until they are released for use or distribution

 All materials and products should be stored under the appropriate conditions established
by the manufacturer and stoke rotation by First Expiry First Out and/or First In First Out
rule.

Record keeping and Documentation

 Every step of work should be documented

 No Record means now work done

 Separate dedicated manpower is necessary

 Different reords should be documented

 BMR, PMR

 Qualtity control reports

 Reagents and materials report

 Records of personnel and manpower

 Records of instruments and equipments

 Recall , reprocessing and destroyed product reports. Etc/.

Miscellaneous

 Drug Manufacturing License should be obtained for manufacturing of drug

 Every manufacturing should get GMP certification which should be renewed periodically

 Special requirement should be fulfilled for manufacturing of special drugs

 Drug manufacturing code 2041 has been revoked