GMP.pptx

Good Manufacturing Practices (GMP) is that part of quality assurance, which ensures that products are regularly produced and controlled according to the quality standards suitable for their use.
Herbal drugs are considered to be adulterated if GMPs are not met.

1. Quality Control & Standardization Of Herbals Good Manufacturing Practice (GMP) By Kaushal Kumar

2. TABLE OF CONTENTS 01 02 03 04 Introduction Objective General Requirements Explanation

3. Good Manufacturing Practices (GMP) is that part of quality assurance, which ensures that products are regularly produced and controlled according to the quality standards suitable for their use. Herbal drugs are considered to be adulterated if GMPs are not met. GMP standards are the only guidelines , alternative processes and control mechanisms that can be used as an essential tool to assure quality. INTRODUCTION

4. → It used in the manufacture of drugs are authentic, of prescribed quality. → Free from contamination. → M anufacturing process has been prescribed to maintain the standards. → Adequate quality control measures are adopted. → M anufactured drug which is released for sale is of acceptable quality. Objective Of cGAP

5. ► Infrastructural Requirement ► Buildings ► Quality Control ► Proper Drainage System ► Water Supply ►Disposal Of Waste ► Containers Cleaning ► Stores → Raw Material → Packaging Material → Finished Goods ► Working Space ► Health, Clothing, Sanitation & Hygiene ► Medical Services ► Requirement Of Sterile Product ► Machinery & Equipment ► BMR ► Distribution Record ► Record Of Market Complaint General Requiremnet

6. ► Infrastructural Requirement Location and surroundings of the pharmacy should be situated where there is - • No open sewage. • No drainage coming from public areas and public lavatory. • No factory fumes. • No excessive soot, smoke and dust. ► Buildings ◘ Buildings should be in hygienic condition. ◘ Sufficient light, ventilation and working space. ◘ No dampness or moisture should be there on the floor and walls. ◘ Wall and floors should be even. ◘ Proper placement of equipment's to avoid risk of mixing and cross-contamination. ◘ The Interior surface should be smooth, easy for cleaning and disinfection. General Requiremnet

7. ► Proper Drainage System ○ Proper ventilation/chimney in the factory. ○ Prevention of flies and dust in factory premises. ○ Proper fire safety measures/exits should be installed. ○ Sanitary fittings and electrical fixtures should be used for safety. ► Water Supply W ater used in manufacturing should be pure and of potable quality. An adequate supply of water is required for washing the premises and containers. ► Disposal Of Waste Waste water and residues are disposed of after suitable treatment as per the guidelines of pollution control to be followed. General Requiremnet

8. ► Containers Cleaning Adequate arrangements for washing, cleaning and drying of containers should be there. ► Stores sufficient space for stores of different types of material such as – RM, PM, FG. The store should have proper ventilation and should be free from dampness. → Raw Material Stores Raw material store should have appropriate containers which would protect the quality of raw materials and prevent contamination, rodents and insects. → Packaging Material Stores All the container and closure lids should be properly cleaned and dried before packing the products. → Finished Goods Stores After the quality control laboratory test and the experts have checked the correctness of FG then it should be moved to the approved FG stock area. General Requiremnet

9. ► Working Space The manufacturing area should provide adequate space for organized placement of equipment and material used in any of the operations. ► Health, Clothing, Sanitation & Hygiene They should use proper uniform suitable to work. Hands should be covered with cloth or synthetic covering. Personal cleanliness, clean towel, soap, scrubbing brushes, separate lavatories for men and women should be maintained. ► Medical Services Annual medical check-up of all employees should be done to ensure freedom from infectious diseases. ► Machinery & Equipment Equipment should be according to the size of operation and the nature of product manufactured. Such as - crushing, grinding, powdering, boiling, mashing, burning, roasting, filtering, drying, filling, labeling and packing, etc. General Requiremnet

10. ► BMR All manufacturing records should be duly signed by production and quality control personnel respectively. It is essential to maintain the record of the date, manpower, machine, equipment used along with the in-process record of various Shodhana . ► Distribution Record Records of sale and distribution of each batch of Ayurveda, Siddha and Unani drugs should be maintained to facilitate quick and complete recall of the batch when needed. ► Record Of Market Complaint Manufacturers should maintain a register to record the complaints as well as corrective action initiated to prevent repetition regarding the products. Once in six months, the complaint records have to be sent to the licensing authority. Reports of any adverse reaction resulting from the use of drugs should be maintained in separate register. General Requiremnet

11. ► Quality Control Every licensee is required to provide a facility for quality control section in his own premises or Government approved testing laboratory. The test should be as per the Ayurveda, Siddha and Unani Pharmacopoeia standard. There should be 150 sq. feet area for quality control section. ► Requirement Of Sterile Product Manufacturing area for the production of sterile Ayurvedic product, the separate enclosed area should be provided. This area should be aseptic, dust-free, moisture less and should have bacteria-free air supply. General Requiremnet

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