Short overview related to GMP

1. Presented by:
Akash Saini
M. Pharm-Pharmaceutics

2. A part of quality assurance aimed at ensuring that products are consistently
manufactured to a quality approapriate to their intended use.
 Concerned with both manufacturing and quality control procedures.
 Applies to both raw material and finished product.
 Compliance with GMP is responsibility of QA department.
That part of QA that ensures that products are consistently produced and
controlled
 Quality standards
 Marketing authorization
Aim: Diminishing risks that cannot be controlled by testing of product:
 Contamination and cross-contamination
 Mix-ups (confusion)

3.  Clearly defined and systematically reviewed processes
 Qualification and validation is performed
 Appropriate resources are provided
 Clear, written instructions and procedures
 Trained operators
 Records of actions, deviations and investigations
 Records for manufacture and distribution
 Proper storage and distribution
 Systems for complaints and recalls
 Complaints handling
 Self-inspection

4. Premises
Primary materials
People
Procedures
Processes defined and recorded

5. It is an important aspect with respect to the suitability of the operations
to be carried out for different dosage forms and
product range:
 Location: avoid cross contamination, dust and dirt build up
 Layout & Design: effective cleaning, minimizing risk of errors
logical flow of material, people and process.
 Construction: lighting(lux), material, ventilation, electrical fittings,
sewage system, pest, rodent & insect control systems.
 Adaptation: Temperature, pressure & RH control systems
(documented)
 Maintenance: cleaning and disinfection and ease of maintenance
(documented)
 Air handling system

6. Proper space for each purpose:
 Warehousing area: adequate space, conditions, material
handling and prevention of cross contamination.
 Production area: adequate space, provisions for material flow
and prevention of cross contamination.
 Quality control area: proper separation, AHU, air lock
systems for sterile area, arrangements for handling and
storage of samples
 Ancillary areas (toilet, change room and maintainence area:
separation from mfg. area
 Quarantine area, separate storage area for raw material and
finished product, recalled product area, etc.

7.  Adequate number of workers as per as requirement
 The working personnel should be properly qualified, experienced and
trained. (documented)
 Their should be organizational structure with well defined responsibilities
of each employee(job description)
 The hierarchy in the oganization should be clear.
 There should be different heads for QC and QA.
 There should be policy for training of employees and periodic assessment
of training programmes,
 Every aspect related to the personnel should be appropriately documented

8.  Purchasing – important operation
 From approved suppliers – if possible, direct from the manufacturer
 Specifications for materials
 Consignment checks:
 Integrity of package
 Seal intact
 Corresponds with the purchase order
 Delivery note
 Supplier’s labels
 Cleaned and labelled with information

9.  Approapriate equipment should be present along with respective log book:
minimizing risk of errors, cross contamination, effective cleaning and
preventing dust build-up.
 Cleaning procedures should be documented with validity periods clearly
defined.
 Parts of equipment should be kept separate.(maintainance)
 Procedures for cleaning equipment after batch production should be well
documented.
 Proper equipment should be present in every area as per as requirements.
 Documented procedure for maintenance and removal of faulty eqipment
should be there.
 Personnel should be trained to operate equipment and training should be
properly documented and evaluated.

10.  Presence of validated system for treatment of water according to
standards with documented source of raw water, pure water and treatment
processes if any.
 Purification of bio burden.
 Distribution and cleaning procedures should be well documented.
 System of disposal of sewage and effluents should be well specified(NOC
from State Pollution Control Board).
 The systems used for disposal should be according to the norms of The
Biomedical Waste Rules, 1996.

11. Documents required:
 Labels
 Testing procedures
 Specifications for starting and packaging materials, for intermediate
and bulk products and for finished products
 Master formulae and Batch Processing Records
 Packaging instructions and Batch Packaging Records
 Standard Operating procedures (SOP's) and records
 Logbooks
 Log cards
 Cleaning , disinfection and maintenance records

12.  According to GMP “if it is not written down, then it did not happen”.
 Recording entries simultaneously
 Recording with date and signature
 Correction with single line cross and signature with date
 Legibility of recording
 Keeping record till retention expiry date
 Never using scratch papers
 Never discarding original raw data
 Signing for work performed
 Direct filling of entries in record books.
 Never sign for the back date

13.  Proper uniforms and adequate facilities for the personal.
 Nature and type of dress should be well documented.
 Pre-medical check-up of employees and periodic assessment of health
standards and hygiene (documented).
 Proper protective for employees working in hazardous conditions.
 Employees should be properly trained to practice high level of
hygiene.
 Cross over benches for separation of production area from other areas.
 Preventing cross contamination.

14.  Starting materials
 Packaging materials
 Intermediate and bulk products
 Finished products
 Rejected, recovered, reprocessed and reworked materials
 Recalled products
 Returned goods
 Reagents and culture media
 Reference standards
 Waste materials
 Miscellaneous
Properly labelled, separated from each other to prevent cross contamination, stored
as per storage requirements, stacking & proper records are maintained.

15.  Procedure for validation studies of processing, testing and cleaning
procedures
 Recording and maintenance of studies and their availability.
 Whether DQ, IQ, OQ & PQ are there for major equipment.
Product recalls: SOPs for recall of products –responsibility,
procedure, reporting and re-reconciliation
Distribution records: inspections before dispatch, auditing of
distribution records and compliance with Good Distribution Practices.

16.  Storage, evaluation, maintainance of reference standards and source of
standards and reference impurities should be known.
 Procedures for preparing working standards from reference standards
 SOPs for all the procedures
 Sampling procedures
 Stability study procedures
 Calibration of instruments and the intervals
 Validation of testing procedures
 Official standard compendia present
 Documentation of validation procedures
 Frequency of revision of STPs.

17.  Products are designed and developed correctly complying with, e.g. GMP,
GCP, GLP
 Production and control operations are defined
 The manufacture, supply and use of correct starting and packaging
materials
 Controls are performed, including intermediates, bulk, calibration and
validation
 Correct processing and checking of the finished product
 Products are sold/supplied only after review by the authorized person
 Procedures for self-inspection and quality audits are applied
 Deviations are reported, investigated and recorded
 System for change control is applied

18.  Purpose is to evaluate whether a company’s operations remain compliant
with GMP
 The programme should cover all aspects of production and quality control
 Be designed to detect shortcomings in the implementation of GMP &
recommend corrective actions
 Set a timetable for corrective action to be completed
 Should be performed routinely
 Also on special occasions such as :
o Recalls
o Repeated rejections
 Frequency should be as per as company requirement
 Performed by experienced, qualified and trained individual of
organization (documented).

19.  GMP is an important component of ensuring QA and quality
 Quality should be built into the product
 GMP's are very similar and are really Good Common Sense
 Good Practices cover all aspects of manufacturing activities prior to
supply
 The role and involvement of senior management is crucial