Presented by: Akash Saini M. Pharm-Pharmaceutics
Jan 22, 2018
Presented by:
Akash Saini
M. Pharm-Pharmaceutics
A part of quality assurance aimed at ensuring that products are consistentlymanufactured 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 andcontrolled
Quality standards
Marketing authorization
Aim: Diminishing risks that cannot be controlled by testing of product:
Contamination and cross-contamination
Mix-ups (confusion)
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
Premises
Primary materials
People
Procedures
Processes defined and recorded
It is an important aspect with respect to the suitability of the operationsto 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 errorslogical 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
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.
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
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
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.
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.
Documents required:
Labels
Testing procedures
Specifications for starting and packaging materials, for intermediateand 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
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
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.
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.
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.
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.
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
Purpose is to evaluate whether a company’s operations remain compliantwith 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 oforganization (documented).
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