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