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RAW MATERIALS : 

Prepared By : Amit $hah M.Pharm Q.A RAW MATERIALS Indubhai Patel College of Pharmacy & Research Centre, Dharmaj

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Contents.. 2

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3 WHAT ARE RAW MATERIALS ? All materials that used into the manufacturing of a finished bulk (even though it may not be present in final product e.g. Certain solvents etc.) and which are consumed by person using it are called as raw materials. Raw materials can be either active drug or inactive substances. eg . Hard gelatin capsules: even though it is used to fill the blend of medicine, it is not considered as package materials because it is consumed by person using medicines.

PURCHASE SPECIFICATION: 

PURCHASE SPECIFICATION Definition : Written guidelines that precisely define the operational, physical, and/or chemical characteristics , as well as the quality and quantity of a particular item to be acquired. rawmaterial.doc Mode of purchasing : By inspection By sample By description of brand By grading 4

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5 Steps involved in purchase procedure : Purchase requisition Selection of supplies Inviting Quotation Placing the order Receiving the material Checking of invoice or bill Recording of bills in books Releasing the payment to the supplier

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6 Staff involved in purchasing have a particular and thorough knowledge of products and suppliers. Raw material can be purchased from supplier named in relevant specification or directly from producer. Specification established by manufacturer for the starting materials be discussed with suppliers. Pharmacist or chemist, who is familiar with quality requirement of various material purchase department can be head of purchase department.

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7 Maintenance of stores Storage Area Specifications :- - Sufficient Capacity - Clean, Dry and Maintained within acceptable temp. limit - Designed and equipped reception area - Ensuring of quarantine status - Separate sampling area - Segregation for storage of rejected, recalled or returned material - Safe and secure area for narcotics and highly active, dangerous and risky material - First in First out rule (FIFO) - First expiring First Out (FEFO)

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8 Storage conditions :- - Room temp. Should be 30° C and R. H. 60% - A.C storage (25± 2 ° C & R.H. 45 – 55%) - Low temp. storage 2 – 8 ° C - Separate area for Sterile product storage in A.C - Light sensitive material in amber color container - Hermitically sealed container Labeling of material in storage area - Designated name of product and internal code reference - Batch no. given by supplier - Status of Content - Expiry date or date beyond which retesting is necessary

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9 During fully computerized system used, labeling with all above information need not be necessary Check list before storage - Integrity of package and seal - Correspondence note for the order, delivery and suppliers labels Check list during storage -separation of rejected, recalled, quarantine, on test, packaging materials. -quality of materials Released by q.c. dept. only

Selection of Vendors: 

Selection of Vendors 10 Purpose :- It is designed to evaluate suppliers and manufacturers with an implementation scheme to assure regulatory compliance. A system which assures that a supplier’s product is produced under controlled conditions, resulting in consistent quality conformance. Require fully involvement and agreement of both partners. Vendor is classified by the finished dosage form manufacturer relative to its credibility .

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Determine the selling price of the API from the vendor, i.e. the cost to the finished dosage form manufacturer. This information is needed for a profitability evaluation of the finished pharmaceutical product Begin the actual process of vendor qualification – evaluation of sample of API . The finished dosage form manufacturer should conduct a vendor audit. Followings are too considered… Response to the quotations invited. The price is lowest or reasonable as compared to the competitors. 11

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His general behavior and attitude when the raw materials are returned by the purchaser and his reputation in the market. SOP and Record of Vendor Certification - Selection of Material based on ABC analysis - Selection of Vendor for above selected material 1. Past history of supplies made by him 2. Trend of quality of material 3. Commitment to quality and delivery dates 4. Compliance of quality parameters - Formation of vendor certification team 12

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13 - Following process components should be studied with supplier or manufactures 1. Study of suppliers mfg. process 2. Product specification and evaluation 3. Process evaluation 4. Process and specification changes & change control system compliance - Carried out and represent Formal technical audit report of vendor. - Based on audit finding vendor can be certified or decertified.

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14 Steps involved in vendor certification process Selection of customer team : to define the objectives & the potential benefits. Supplier selection . Initial supplier contacts. Process elements: 1. supplier process. 2. specification 3. process evaluation Process and specification changes. Customer specification. Supplier reporting : 1. certificate of compliance from supplier 2. feedback form to supplier. Decertification : lesser status of “ approved” or “ preferred” Adv. of certification process: - the tighter specification range. - reducing testing by customer . - cost reduction

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15 SOP on receipt , storage ,sampling of materials. Receipt of materials : Visual examination for all incoming materials Intact container, lid, seals Evidence of any physical damage to the containers Evidence of rodent or insect specification. Proper labeling in specified manner Points to be checked & recorded Date of receipt Name of product, batch no., control no. assigned by manufacturer. Quantity received against document Name of supplier Purchase order no. Excise gate pass etc.

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16 Storage of materials : External cleaning of container after receiving &before storage Quantity verification Storage in specified area as per condition R.T./ A.C./ Cool /cold/ low humidity area. Storage as per quarantine status of the material received, sampled, approved, rejected . Sampling of materials: Sampling responsibility Sampling formula used Method of sampling e.g. top, middle, bottom sample is required

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17 Material wise quantity to be sampled as per requirement of analysis. Sampling room specification: Temp. Relative humidity Air pressure iii. Specific requirement for specialized product: Sterile products Poisons or potent drugs Beta lactum products Sex hormones Steroids

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18 Opening and closing of containers before & after sampling. dress code of people doing sampling Cleaning, drying, sanitization of utensils used for sampling. Identification of sampled containers Sampled containers and sample collection containers should have following details : Name of materials & manufacturer Batch no. for manufacturer Date of sampling Name & sign. Of sampler etc.

CONTROL ON RAW MATERIALS: : 

CONTROL ON RAW MATERIALS: Quality assurance should make periodic sanitation and follow up to assure that deficiencies are corrected. Raw materials with abnormally high microbial contamination may have to be subjected to a sterilization procedure like heat treatment, radiation or crystallization from a bactericidal solvent like alcohol. Warehouses are the first operational area observed by the auditor to check operational compliance with cGMP & FDA regulation. Following elements need to be considered when establishing warehouses operation: cleanliness , floors , lighting & SOPs . 19

Finished Products: 

Finished Products 20 A product in the marketable pack Practically a transportable pack E.g. shipper containing salable material SOP for controlling (transfer, storage) of finished products. Transferring of finished packs from transportable packs to finished goods warehouse with finished goods transfer note giving batch no., quantity, date, time, etc. Collect and analyze the samples specification against using validated test methods. part of sample kept as retained material for it SOP. List of products should be provided to finished goods store.

Indian Pharmaceuticals Limited Full scale calibration of weighing balance.: 

Indian Pharmaceuticals Limited Full scale calibration of weighing balance. Sr no Calibration date Calibrated for wt Observed for wt. deviation Calibrated by Checked by 21 Balance code:--------- ref SOP no: ------------ Weighing m/c no: ------- Capacity Min: --------- Location no : --------- Capacity Max : ------- Calibration no : ------ Month : ----------- Valid up to : ---------- Frequency : --------- Usage capacity : Min. ------ Next calibration due on : -------- Max. --------

Indian Pharmaceuticals Limited List of standard weights: 

22 Indian Pharmaceuticals Limited List of standard weights Sr no. weights Date of calibration Validity of collection Remarks in any 1 1.0 kg. 2 0.2 kg. 3 0.5 kg. 4 2.0 kg. 5 5.0 kg. 6 Etc. 7 8

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23 Indian pharmaceutical limited Balance cleaning record. Date Type of balance Code no. of balance Time of cleaning From To Cleaned by Checked by

Indian pharmaceutical limited Daily gross check of balance: 

Indian pharmaceutical limited Daily gross check of balance 24 Location : Ref . SOP no: Type of balance : Model no: Code No. : Capacity: min :---- max: ---- Month : Date Zero checked by remark sign date Zero checked by remarks sign

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25 Sr.no . Material Name Synonymous Name/brand name Date of receipt Name of Manufacturer supplier Quality receipt Invoice No.& Date 1. 2. Indian Pharmaceuticals Limited Raw material receiving observation sheet

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26 Name of Materials Claimed grade (IP/BP/USP) Import or mfg. LIC. no Name and address of manufacturer Name of packer or trader if any Inner lining of bags Checked against specification no. Indian Pharmaceuticals Limited Raw material sampling observation sheet Ref. SOP. No.

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27 Sr no Batch No Quantity Mfd. Exp. No of packs sampled Sample qty. Container No. Sampled Qty. Per Pack No. of pack Total Qty. Sr. No. Batch no. No. Pack Damaged Type of Damaged Remarks Observation during Sampling : Form: __________ Color: ________________ Odor: __________ Foreign matter: __________ Spillage if any: _______ Sampled by: Name: _________ Date:_____ Sample Handed: A Ref No. ________________ Over to: __________

Daily stores Inward Reports of R.M Date:: 

Daily stores Inward Reports of R.M Date: 28 Sr. No. Name of Items Quantity on Challan Name of Party Temperature and Relative Humidity Record Department Month Area Prescribed Range For Temp °C For % RH Room No. Ref. SOP. No. Date Time Dry bulb temp °C Wet bulb temp °C % RH Initials of Officers Remarks

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29 References CGMP for Pharmaceuticals by Manohar A. Potdar GMP for Pharmaceuticals , Fifth edition , by Sidney H. Willing. Pharmaceutical Industrial Management by G.Vidyasagar. gmp-quality.com

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