Harish

Dept. Of Pharmacy (INDUSTRIAL PHARMACY)

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GOOD MANUFACTURING

PRACTICESPresented By :-

Harish Chandra.S (10U21S0804) M.Pharmacy (Industrial Pharmacy)

Under Guidance of :-Mr. Prasad Rao

SREE DATTHA INSTITUTE OF PHARMACY


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CONTENTS

• Introduction

• Why GMP

• Various Guidelines

• Guideline Versions

• Enforcement

• GMP Requirements

• Conclusion

• References


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INTRODUCTION

“Good manufacturing practice” or "GMP" is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods ,pharmaceutical products and medical devices.

GMPs are guidelines that outline the aspects of production and testing that influences the quality of a product.

GMP requirements are specifically mentioned in ‘Schedule M’ of the “Drugs and Cosmetics Act 1940”


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WHY GMP ?

• A poor quality medicine may contain toxic substances that have been unintentionally added.

• A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect.


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VARIOUS GUIDELINES

Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation.

But there are some guidelines that all the countries should comply with , to maintain a standard quality of a product, such as :

- US-FDA (United States Food and Drug Administration)

- ICH (International Conference on Harmonization) - WHO (World Health Organization)


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GUIDELINE VERSIONS

• FDA - US

• The Orange Guide (officially - Rules and Guidance for Pharmaceutical Manufacturers and Distributors)- UK

• EUGMP – European Union


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Although there are a number of guidelines, all follow a few basic principles :

• Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.

• Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.

• Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)

• Operators are trained to carry out and document procedures

• The distribution of the drugs minimizes any risk to their quality.


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• Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.

• Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.

• A system is available for recalling any batch of drug from sale or supply.

• Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.


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ENFORCEMENT• European Union - National Regulatory Agencies

• United Kingdom - Medicines and Healthcare products Regulatory Agency (MHRA)

• Republic of Korea (South Korea) - Korea Food and Drug Administration (KFDA)

• Australia - Therapeutical Goods Administration (TGA)

• South Africa - Medicines Control Council (MCC)

• Brazil - Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency Brazil) (ANVISA)

• Iran, India and Pakistan - Ministry of Health


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QUALITY, QUALITY CONTROL, QUALITY ASSURANCE

Quality: The totality of features & characteristics of a product that bear on its ability to satisfy stated need (Quality is “Meeting the Standards”)

Quality Control (QC): A technique for securing quality of the manufactured product which includes analysis, sampling, inspection for defects, as well as evaluation of raw & finished products.

Quality Assurance (QA): It ensures that the facilities & equipments are in order, production department uses adequate systems and procedures, processes are adequately documented and that the QC department does its job adequately and completely.


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Validation: Assurance of specific process which consistently

produces a product meeting all the predetermined specifications and quality attributes.

It includes validation of equipment, personnel, services, packing & labeling, SOP’s, warehousing & distribution and of documents.

Types:-Prospective Validation-Retrospective Validation-Concurrent Validation-Revalidation


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GMP REQUIREMENTS • General Requirements:• Location and surroundings: Avoiding risk of contamination, to

prevent disagreeable odor/fumes, dust, smoke etc,.

• Buildings and Premises: Hygienic conditions be maintained. Mix-up of various drugs, and possibilities of contamination be avoided.

• Water Systems: Validated system for water treatment with standards specified by the authorities. Microbial growth is prevented during storing.

• Waste disposal: Should meet the requirements of Pollution Control Board.


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• Ware housing area

• Good storage conditions, clean, dry, acceptable temperature limits.

• Separate sampling area for raw materials and excipients.

• Hazardous, poisonous, explosive materials, psychotropic drugs are stored in safe and secure areas.

• Regular checks are made.


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• Production area

• Should be uniflow with logical sequence of operations.

• Separate areas for sensitive products (penicillin,biologicals).

• Pipeworks, Electrical fittings, Ventilation are designed to avoid the dust accumulation.

• Service lines should be identified by colors and the nature of supply & direction of flow be marked.


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• Ancillary Areas

• These areas are separated from other areas.

• Facilities for changing, storing clothes , for washng should be easily accessible and not connected directly to production area.

• Maintenance rooms shall be separated from production.

• Animal housing shouls be sepatare from other areas.


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• Quality Control Area

• Should be independent of production areas and separate areas be provided for physico-chemical, biological, microbiological analysis.

• Separate instrumentation room.

• Avoid mixup and cross contamination.

• Separate air handling units for biological, mircobiological, radioisotopes testing areas.

• Regular water supply for cleaning and testing purpose.


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• Health, Clothing & Sanitation:

• Personnel handling β-Lactum antibiotics shall be tested for penicillin sensitivity and should undergo medical examination including eye examination.

• Trained in practices which ensure personal hygiene.

• No person showing illness shall be allowed to handle starting or parking materials until his condition is out of risk.

• All personnel shall be instructed to report their illness to the supervisor.

• Shall wear clean body coverings appropriate to their duties.

• Smoking, eating, drinking, chewing/keeping plants, food, drink, and personal medicines shall not be permitted in production, laboratory, and other areas.


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• Manufacturing operations and controls

• Under the supervision of technical staff approved by licensing authority.

• Prevent mix-up and cross-contamination of drug materials.

• Packaging lines should be independent and adequately segregated.

• Work area, packaging lines, printing machines, and other equipment should be clean from any products before starting the packing operations.

• Manufacturing environment at required levels of temperature, humidity and cleanliness.


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• Raw materials

• All raw materials shall be purchased from approved sources, quarantined immediately after receipt and stored under proper conditions.

• QC department shall check each consignment on receipt and shall check the integrity of each package & seal.

• Raw materials in storage area shall be appropriately labelled.

• Separate areas for materials “under test”, ”approved”, ”rejected” shall be maintained.

• All raw material containers are placed on the raised platform and not directly on floor.


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• Equipment

• Shall be located, designed, constructed, adapted and maintained to suit the operations to be carried out.

• Minimize the risk of errors and permit effective cleaning and maintenance to avoid cross-contamination, dust build-up etc,.

• Calibrated and checked on scheduled basis in accordance with SOP’s.

• Parts of equipment shall not be reactive, additive that would affect the quality of product.

• Lubricants used in the equipment shall not contaminate the products.

• Defective equipment shall be removed.


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• Labels and other printed materials

• Necessary for the identification of the drugs .

• All containers and equipment shall bear appropriate labels.

• Prior to release all labels shall be examined by QC department.

• Records of receipt of all labeling and packing materials are maintained for each shipment


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• Master formula records

• Name of the product with reference code relating to its specification.

• Patent name of product along with generic name, description of dosage form, strength, composition of product and batch size.

• Detailed stepwise processing instructions and time taken for each step.

• Instructions for in-process controls.

• Any special precautions to be observed.

• Packing details and specimen labels.


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• Packaging records

• Name of the product.

• Description of dosage form, strength and composition.

• List of all packaging materials required for standard batch size, including quantities, sizes and types with codes.

• Description of packaging operations including any equipment to be used.

• Upon completion, a reconciliation shall be made between number of labeling and packaging units issued, and labeled.


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• Standard Operating Procedures (SOP’s)

• Written SOP’s for receipt of labels, for each equipment and instrument, for sampling, batch numbering, testing, records of analysis, etc,.

• Reference samples

• Each lot of every active ingredient shall be retained for a period of 3 months after the date of expiry.

• Samples of finished formulations shall be stored in the same containersin which the drug has been carefully marked.


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CONCLUSION


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REFERENCES

• http://en.wikipedia.org/wiki/Good_manufacturing_practice

• Forensic pharmacy- B.S.Kuchekar (Nirali Prakashan Publishers)


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Harish

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