Bhairavi Satpudke

1. CHHATRAPATI SHIVAJI COLLEGE OF PHARMACY DEORI DISTRICT - GONDIA • SUBJECT - PHARMACEUTICALQUALITYASSURANCE • TOPIC - EQUIPMENT & RAWMATERIALS • PRESENTEDBY -BHAIRAVIVIJAYSATPUDKE • CLASS -BPHARM3RDYEAR • UNDER THE GUIDANCE OF – PROF.CHANDRASHEKHARBADWAIKSIR

2. DEFINATION:: • EQUIPMENT:: It can be defined as physical entity which is used to carry out a general or specific activity in the pharmaceutical plant. Example:: tablet compression, weighing machine. • RAWMATERIAL :: All materials that are used in the manufacturing of a finished bulk( even though it may not be present in final product) are called as raw material. • Raw material can be either active or inactive substances .Example ::Excipients ,Water ,Glass .

3. INTRODUCTION • Location, design, construction, adaptation, and maintenance of equipment should as per the operations to be carried out. • The major aim of layout and design of equipment should be to reduce the risk of errors and allow effective cleaning and maintenance so the cross – contamination , accumulation of dust or dirt ,and any adverse effect on the product quality can be prevented. • MATERIAL : The pharmaceutical plant is mainly established for producing finished products by using starting ,gases, solvents ,process aids , reagents ,and labelling materials are required for pharmaceutical preparations. • The product should not be exposed or be in direct contact with the materials used for cleansing and lubrication of equipment and pest control. • After receiving or processing of incoming materials and finished products they should be quarantined before their distribution. • Storage of all materials to allow batch segregation and stock rotation by first – expire , first – out rule. • Suitable water should be used for manufacturing of pharmaceutical products.

4. The quality of the manufactured product much depends on the suitability, level of the technology of the equipment used since it is major requirement in the manufacture of the pharmaceutical products. • SELECTION OF EQUIPMENT • Selection of equipment has both strategic and financial impact on companies. • It has direct influence on the success of the product facilities by optimum cost ,improving quality ,safety and reducing environmental hazards. • Equipment of appropriate design and adequate size should be used. • The manufacturing equipment should be located suitable for its intended use cleansing, sanitation ,and maintenance. • The materials used for construction should be such that their contact with raw materials intermediates ,or APIs does not alter their quality beyond the official limits or other established standards.

5. Some major equipment ( Example : reactors and storage containers) and permanently installed processing lines used for intermediate or API production should be properly identified. • Lubricants , heating fluids ,or coolants are substances used in the operation of equipment. Such substances should not come in contact with intermediates or APIs to prevent alteration in their quality beyond the official limit or other established standards . • If any deviation from the specified limit is found ,it should be evaluated and ensured that the material quality was not adversely affected. • CHEMICAL REACTORS ♦️ PROCESSING LINES

6. PURCHASESPECIFICATIONS • The properties associated with an item or products to be purchased include weight ,size , dimensions, quality and safety requirements ,and the products performance parameters. • Be purchasing equipment ,the following aspects should be considered. • 1) The equipment should be compatible with user requirements specification • 2) The following questions regarding the design ,size , location , adaptation and construction of the equipment should be asked:: • i) Why the equipment should be purchased? For Example – Creating new facility , increasing capacity, or adapting to new improved technology. • Ii) Which operations are proposed to be performed using the equipment? For Example- Equipment capability analysis , granulation ,or sterilisation. • Iii) What should be the capacity of the equipment in terms of output and holding .For Example-Ten lac tablets per shift or ten thousand litres of liquid.

7. iv) What is the cleansing process of the Equipment ? And whether any problem occurs while validating the cleaning process of the equipment.? • v) Are trained operators available for operating the equipment ? Or whether the manufacturer provides training of the existing operator. • Vi) What will be the operation time ( starting and stopping time ) of the equipment? • SomeoftheimportantPurchaseSpecificationsThatShouldBeConsidered:: • Desiredoutputcapacity – Equipment purchased must be capable of processing desired quantity of product at the desired speed of operation. • Product Characteristics- The nature of the product ,it’s reactivity any special conditions necessary to ensure retention of its safety , efficacy and quality are important. • Ease Of Operation- Equipment operation must be simple ,and not involve complex skills .The equipment must be easy for the operator to operate after receiving proper training.

8. Ease Of Cleaning & maintenance – Equipment will require cleaning and special more thorough cleaning between batches of different products. The time used for cleaning is the time loss from manufacturing. So equipment must be easy to clean and maintain. • Equipment Supplier – Price is often considered as an important criteria ,but it is also important to consider quality before purchase of an equipment. Also the reputation of supplier should be considered. • FOLLOWING FACTORS ARE TAKEN INTO CONSIDERATION WHILE PURCHASING A MATERIAL • Right Source • Right Quality • Right Quantity • Right Price • Right Time • Right Mode Of Transportation

9. OVERLOOKOFEQUIPMENTSPECIFICATION • Location & design. • Preventive & Breakdown Maintenance. • Construction. • Size & Adaptation. • Cleaning & Cross Contamination . • Installation & Calibration . • Qualification & Validation. ♦️ REFERENCE-♦️ Prof.(Dr.) RSundhararajan . ♦️ Dr . MV . Kumudhavalli . ♦️ Dr.MinalHarde .