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GMP (SCHEDULE-M) By Virendra singh M.pharm (1 st sem ) Department of Pharmaceutics Roorkee college of Pharmacy Roorkee

Definition :

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 :

The Early Beginnings 1900’s- house-calls Home remedies, ointments and “miracle elixirs” No regulations until 1902

Public Involvement:

Public Involvement 1905 - The Jungle by Upton Sinclair Exposure of unsanitary Meat packing plants. Increased Public awareness And involvement Pure Food and Drug Act False labeling became illegal

A Time line of GMP :

A Time line of GMP 1902 - Development of the Biologic Control Act 1906 - Development of the Pure Food and Drug Act 1938 - Federal Food, Drug and Cosmetic Act 1941 - Initiation of GMP 1944 - Development of Public Health Services Act 1962 - Kefauver-Harris Drug Amendments released 1963 - Establishment of GMPs for Drugs 1975 - CGMPs for Blood and Components Final Rule 1976 - Medical Device Amendments 1978 - cGMPs for Drugs and Medical Devices 1979 - GLPs Final Rule 1980 - Infant Formula Act is passed

1941 Initiation of GMP:

1941 Initiation of GMP Sulfathiaziole tablets contaminated with phenobarbital 1941 - 300 people died/injured FDA to enforce and revise manufacturing and quality control requirements 1941 - GMP is born Thalidomide tragedy Thousands of children born with birth defects due to adverse drug reactions of morning sickness pill taken by mothers Strengthen FDA’s regulations regarding experimentation on humans and proposed new way how drugs are approved and regulated “Proof of efficacy” law

Slide 7:


Areas to be Covered :

Areas to be Covered General considerations Personnel Premises Equipment Sanitation SOP’s Raw Materials Self Inspection And Audit Master Formula Records Batch Manufacturing Records

Areas to be Covered(cont..):

Areas to be Covered(cont..) Warehousing Area Reference Samples Validation and process validation Labels And Other Printed Materials QA

General considerations:

General considerations Compliance with GMP Consistent uniform batches Location And surroundings Water system Disposal Of Waste




PERSONNEL Qualified Personnel a)Experienced b)Sufficient Number Written job description Trained Health a)Diseases b)Open Lesions




Premises Points to be Consider Location Design Construction


Premises Location Geography, climate,and economic factors Neighbours 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 Location(cont..)


Premises Design Minimize risks of errors Permit effective cleaning Permit effective maintenance Avoid cross-contamination, build-up of dirt and dust Maximum protection against entry of insects, birds and animals Separate 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 Hygiene Eating,Drinking,Smoking Should not be allowed in the Production area.


Premises Construction Measures should be taken to prevent cross-contamination Dust control measures (including extraction of dust and air) No areas for dust accumulation Easily cleanable surfaces Proper air supply Use of HEPA filter’s


Premises Finishing floors,walls,and Ceilings Should be smooth, impervious, hard-wearing, easy to clean




Equipments Equipment 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


Sanitation Written procedures hygiene, health and clothing practices waste disposal Implementation and training


Sanitation Practices not permitted a) eating, smoking b) unhygienic practices

Standard Operating Procedure:

Standard Operating Procedure

Standard Operating Procedure:

Standard Operating Procedure There shall be written Standard Operating Procedure for each operation It include- a)For Eqipments b)For sampling c)For Testing d)For Process f)For Packaging

Raw Materials:

Raw Materials

Raw Materials :

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 U Should be purchased from approved sources Must be checked by QC department on recipt Should be labeled.

Self Inspection And Audit :

Self Inspection And Audit Regular 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 Records :

Master Formula Records There shall be MFR relating to all manufacturing procedures for each product and batch size to be manufacture It 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 Records:

Batch Manufacturing Records There shall be Batch processing record for each product. During Manufacturing or Processing the following information shall be recorded It include- The name of the product The number of Batch being manufactured Dates and time of commencement of batch and completion Initials of operator Amount of Product obtained

Warehousing Area:

Warehousing Area

Warehousing Area :

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 Samples:

Reference Samples

Reference Samples :

Reference Samples Should 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 Samples :

Reference Samples Samples of finished formulations shall be stored in the same containers in which the drug has been actually marketed

Reference Samples:

Reference Samples

Validation and process validation :

Validation and process validation Essential part of GMP Necessary to achieve the intended results A written record is prepared summarizing recorded result and conclusions shall be prepared ,documented and maintained Should 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 Materials:

Labels And Other Printed Materials

Labels And Other Printed Materials:

Labels And Other Printed Materials All containers and equipment should bear labels Different 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..) :

Labels And Other Printed Materials(cont..) The Printing should be done in bright colours The label should contain all the prescribed details about the product.

Quality Assurance:

Quality Assurance

Quality Assurance:

Quality Assurance The 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 material ii)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. FDA Food and Drug Administration. GMP Combination Handbooks. 31 Aug. 2008. WHO Technical Report Series, No. 929, 2005

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