1
GMP (SCHEDULE-M)
BYDr. Suman PattanayakAssociate ProfessorDepartment of Pharma Analysis & QA.
Vijaya Institute of Pharmaceutical Sciences for Women
B. Pharm IV year/ II SemDRA, IPR & Patents
Definition That part of QA which ensures that products
are consistently produced and controlled to the quality standards as per the specifications.
The Early Beginnings 1900’s- house-calls Home remedies, ointments and “miracle
elixirs”No regulations until 1902
Public Involvement1905 - The Jungle by Upton SinclairExposure of unsanitary Meat packing plants.Increased Public awareness And involvementPure Food and Drug ActFalse labeling became illegal
A Time line of GMP 1902 - Development of the Biologic Control Act1906 - Development of the Pure Food and Drug Act1938 - Federal Food, Drug and Cosmetic Act1941 - Initiation of GMP1944 - Development of Public Health Services Act1962 - Kefauver-Harris Drug Amendments released1963 - Establishment of GMPs for Drugs 1975 - CGMPs for Blood and Components Final Rule1976 - Medical Device Amendments1978 - cGMPs for Drugs and Medical Devices 1979 - GLPs Final Rule1980 - Infant Formula Act is passed
1941 Initiation of GMPSulfathiaziole tablets contaminated with phenobarbital1941 - 300 people died/injured FDA to enforce and revise manufacturing and quality control
requirements1941 - GMP is born Thalidomide tragedyThousands of children born with birth defects due to adverse
drug reactions of morning sickness pill taken by mothersStrengthen FDA’s regulations regarding experimentation on
humans and proposed new way how drugs are approved and regulated
“Proof of efficacy” law
Areas to be Covered
General considerationsPersonnelPremisesEquipmentSanitationSOP’sRaw MaterialsSelf Inspection And AuditMaster Formula RecordsBatch Manufacturing Records
Areas to be Covered(cont..)Warehousing AreaReference SamplesValidation and process validationLabels And Other Printed MaterialsQA
General considerations
Compliance with GMPConsistent uniform batchesLocation And surroundingsWater systemDisposal Of Waste
PERSONNELQualified Personnel a)Experienced b)Sufficient Number
Written job descriptionTrainedHealth a)Diseases b)Open Lesions
Premises LocationGeography, climate,and economic factorsNeighbours a) What do they do? Premises must be located to minimize risks of cross-
contamination, e.g. not located next to a malting factory with high airborne
levels of yeast
Pollution/effluent control
Premises DesignMinimize risks of errorsPermit effective cleaningPermit effective maintenanceAvoid cross-contamination, build-up of dirt and
dustMaximum protection against entry of insects, birds
and animalsSeparate facilities for other products such as some
antibiotics, hormones, cytotoxic substances
Premises Design(cont..)Maximum protection against entry of insects, birds and animals Specific Areas 1) Production areas 2) Quality control areas 3) Weighing areas 4) Storage areas 5) Ancillary areas
Premises ConstructionMeasures should be taken to prevent cross-
contaminationDust control measures (including extraction of
dust and air)No areas for dust accumulationEasily cleanable surfacesProper air supplyUse of HEPA filter’s
Premises Finishing floors,walls,and Ceilings Should be smooth, impervious, hard-wearing,
easy to clean
EquipmentsEquipment shall be
located,designed,construcetd,adapted and maintained to suit the operation to be carried out.
Should be made of non reactive material,such as High grade of steel(316,302)
Equipment should be- a) Caliberated b)Checked c)labelled d)Sterilized
SanitationWritten procedures• hygiene, health and clothing practices• waste disposalImplementation and training
Standard Operating ProcedureThere shall be written Standard Operating
Procedure for each operationIt include- a)For Eqipments b)For sampling c)For Testing d)For Process f)For Packaging
Raw Materials An Inventory should be maintained for Raw
materials to be used at any stage of manufacture
Records should be maintain as per Schedule UShould be purchased from approved sourcesMust be checked by QC department on recipt Should be labeled.
Self Inspection And AuditRegular independent inspection is necessary
to evaluate the manufacturer’s compliance with GMP in all aspects of manufacturing
Procedure for self inspection shall be documented indicating
a)Evaluation b)Conclusion c)Recommendations for Corrective action
Master Formula RecordsThere shall be MFR relating to all manufacturing procedures
for each product and batch size to be manufactureIt should include- i)The name of the product ii)Quantity,of all starting materials to be used iii)A statement of the expected final yield with acceptable
limits. iv) Principal equipment to be used v) Detaild stepwise processing instructions and the time
taken for each step vi)Any special precations vii)Packing details and Specimen labels
Batch Manufacturing RecordsThere shall be Batch processing record for each
product.During Manufacturing or Processing the following
information shall be recordedIt include-The name of the productThe number of Batch being manufacturedDates and time of commencement of batch and
completionInitials of operatorAmount of Product obtained
Warehousing Area
Warehousing area should be designed and adapted to ensure good storage conditions.
Should be Clean,dry and maintained with acceptable temperature limits.
Should have appropriate house-keeping and rodents,pests and vermin control.
Seprate sampling area for active raw material and excipients.
Every Material stored should be labeld properly.Fire Prevention
Reference SamplesShould be taken in sufficient quantity from
each lot of active ingridient to carry out all the tests
These samples should be retained for a period of 3 months after the date of expiry of the last batch produced from that active ingridient
Samples of raw material should be stored in suitable container(plastic or glass) as mentioned in the SOP
Reference SamplesSamples of finished formulations shall be
stored in the same containers in which the drug has been actually marketed
Validation and process validation Essential part of GMPNecessary to achieve the intended resultsA written record is prepared summarizing recorded result and
conclusions shall be prepared ,documented and maintainedShould be necessary when- a)Any new new master formula or method of prepration is adopted b)For critical process c)any changes in the equipment,or when using a new equipment,it is first validated to demonstrate its consistentency of required quality
Labels And Other Printed MaterialsAll containers and equipment should bear
labelsDifferent colour coded labels should be used
to indicate the status of a product(for example under test,approved,passed,rejected)
Labels And Other Printed Materials(cont..)The Printing should be done in bright coloursThe label should contain all the prescribed
details about the product.
Quality AssuranceThe main objective of the quality assurance is to
ensure the products are of the quality required for their intended use
Functions-i)Adequates are made for manufacuring,supply and
the use of correct starting and packing materialii)Adequate control on starting
material,intermediate,and bulk products.Iii)Process validation in accordance with established
procedures
References Blackwell, John. 1906: Rumble Over ‘The Jungle’. 31 Aug.
2008. http://www.capitalcentury.com/1906.html FDA Food and Drug Administration. GMP Combination
Handbooks. 31 Aug. 2008. http://images.google.com WHO Technical Report Series, No. 929, 2005
Top Related