quality control lab BY ANIL

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Quality control:- Definition:- As per WHO, QC is the parts of GMP concerned with sampling, specification, testing with the organization documentation & releasing procedure which ensure that the necessary and relevant test are actually carried out and that materials are neither released for use nor produces released for scale or supply until their quality has been satisfactory

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In short QC is not confined to laboratory operation but must be involve in all decision concerning the quality of product. Main responsibility of Q.C. units : Samples Testing Approval &rejection of materials Recording & storage of materials data

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The principal duties of the Q.C.U. are listed : It should approve :- Specification &testing method for starting material, intermediate product & finished product, if requiredpackaging materials & APIS Sampling procedure Instruction regarding sanitation &hygiene Reprocessing procedure for rejected batch or recovered materials. Other instruction related to the quality of the product .

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2. Responsibility & authority :- Q.C.U. that have the responsibility and authority to approve or reject all component drug product container closure. In process materials, packaging materials labeling and drug product. 3. Stability ensure:- Q.C.U. should ensure that the stability of active pharmaceutical ingredients is monitored. Many APIs products are very stable and may not require extensive testing to check stability.

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4 Investigation of complains:- It should be responsible for the investigation of complaints related to the quality of active pharmaceutical ingredients, in process materials & finished products. T he disposal procedure for waste material and unusual residues. In Q.C. lab aprone must be wear during the analysis of drug. Smoking &unhygienic particle should not be permitted in Q.C. lab.

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5 Responsibility for labeling:- Q.C.U. is also resposib;e for appropriate or rejected labeling This new or modified labeling should be reviewed to ensure that it courlies with the ANDA, NDA over counter monograph. This checking may be delegated to other function but the Q.C.U. must ensure that the checkers are qualified to perform their function and that they have done so, Complaints received from consumers, profession and the trade serve as a primary means of obtaining feedback about product quality after distributi on

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Routine controle instrument:- r.c.i In other words we can say the calibration and verification of instrument at regular interval. Calbration and verification of instrument is important to approch best qaulity . if the instrument are not calibrated than gives a differ result during the analysis and it’s directly effect to the quality. A] CALIBRATION SCHEDULES B]PERSONNEL QUALIFICATION C]CALIBRATION POGRAME D]TRACIBILITY TO STANDERED a}national b}regional c} international E]INDICATION OF STATUS Calibration & varification of instrument & other devices, as applicable used in q.c . should be perfomed at regular interval. Ex: daily calibration ph meter, Weight calibration etc. Dissolution appratus – 1 months Uv –visible spectroscopy-1 months Karl fisher instrument - 3 months Ovan -6 months

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A calibration programme should be available and should provide information , calibration std. & limits responcible persons, calibration intervals , records and action to be taken when problem are identified. Calibrated instruments and other devices should labelled coded or otherwise identified to indicate the status calibration and the date on which recalibration is due. pH calibration sheeet Department : Q.C. Lab ( instrument Room ) month Oct’09 Ph 07 Ph 04 Date by Done by Remark

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Laboratory records:- Laboratory records should includeds complete data derived from all tests, necesaary to ensure complaing with establish specification & std. including examination & assay as follow. Record of description record of sample Statement of methodology Specific component Calculation formula Results of taste Others Signature, date of taste

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UNIQUE PHARMACEUTICALS TEPERATURE & RELATIVE HUMIDITY RECORDS Department : Q.C. lab Month : oct’09 Area : Istruments room Prescribed Range : For temp: For % RH : Room No: Ref sop no : Date Time Dry bulb temp. Wet bulb temp. % RH Checked by Remark (if any)

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Reagents:- 1.All reagents for test should be of/appropriate quality. Reputed manufacturers, Purchase in small containers. 2.Appropriate safety regulations should be drawn up and implemented. Toxic/inflammable reagents- “poison’’ Locked cabinets. 3.Laboratory prepared reagents includes solutions like volumetric , buffers , indicators , reference standard and general reagents. Labeled with:-name of reagents , strength /factor , date of preparation and standardization , initials of person preparing the reagent , expiry date , storage conditions , reference to source of raw data. 4.Responsibility of the reagents should be clearly assigned. Making and standardization No unnecessary transfer from unit to unit.

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5.Distilled water and dionized water should be regent and precautions from contamination should be taken. Stocks checked every month [minimum] Specific conductance at 20*c should be NMT 2x10­ -6 ohm -1 cm -1 and chlorine content should meet Pharmacopoeial requirements. 6.All containers should be checked for the seals. Both when in store and when distributed. If appears tampered, reagents either rejected or checked for purity. 7.Store should be stocked up with clean bottles, vials, spoons, funnels and labels required for dispensing reagent from larger to smaller containers. 8.Maintaining stocks can provide continual supply as and when required. 9.In large laboraties separate rooms may be provided for- Flammable substances Self igniting materials like Na, K etc. 10.All storage areas are equipped with fire regulations.

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Sampling plans “ Sampling plans is the one which is to be established which involves decision as to when, where and how the sample should be taken and whether the process of sampling should be a one-off or it should be repeated and how often ” It is of two types Attributor plans : A random sample is taken from the lot and each unit is classified as acceptable or defective. The number of is then compared with the allowable number stated in the plan and a decision is made to accept or reject the lot. Variable plans : A sample is taken and a measurement of a specified quality characteristic is made on each unit. These measurements are then summarized in simple statistics, and the observe value is compared with and allowable value defined in the plan. A decision is then made to accept or reject the lot

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some plan developed as followed * N plan * R plan * P plan N PLAN These plan is based on one formula Samples can be withdrawn from any part of the containers & same times sample collected from 3n layers FORMULA N=1+n 1/2 Where n = no of containers If n is less than or = 4, then every container is sampled.

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P PLAN P plan may be used when the materials is received from a recognized source FORMULA P=0.4n 1/2 The value for p are obtained by rounding up to the next highest integer. If the results are concordant, P final samples are formed. R PLAN The r plan may be used when materials is suspected to be uniform and/or is received from a source then is not well known. FORMULA R=1.5n 1/2 The figure for R obtained by rounding up to next highest integer. Sample are taken from each of the N sampling units of the consignment & placed in separate sample container.

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STANDARD TEST PROCEDURES:- Testing procedure described by documents should be validated in the context of available facilities and document before they are adopted for routine testing. STP should be described in detail and should be provide sufficient information to allow properly trained analysts to perform the analysis in reliable manner. As minimum, the description should include the chromatographic condition ( in case of chromatographic tests ) reagents needed reference standards the formula for the calculation of results and system suitability tests.

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Characteristics of standard teat procedure:- 1.Accuracy 2.Precision 3.Repetability 4.Robustness 5.Linearity 6.Range 7.Specificity 8.Detection

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Format for s.t.p SUN PHARMA PHARMACETICALS NAME: PAGES: CODE NO: SHELF LIFE: STATUS: EFFECTIVE DATE: STP NO.: REVIEW PERIOD: PREPARED BY: CHEKED BY: APPROVED BY: SIGN.: DATE:

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PROTOCOL Protocol is a system of rule about the correct way to act in formal situation . Each study shall have an approved written protocol that clearly indicates the objective and all methods for the conduct of study.

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Protocol should contain the following items:- Title and statement of the purpose of the study Identification of the test and control articles by names, chemical number or code number. The name of the sponsor and the name and address of the testing facility at which the study is being conducted. The number, body weight range, sex, source of supply, strain, sub strain and age of the test system. The procedure for identification of the system.

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A description or identification of the diet used in study. Each dosage level expressed in milligrams per kilograms of body weight or other appropriate unit and frequency of administration. Type and frequency of test, analysis and measurements to be made. Records to be maintained. The date of approval of the protocol by the sponsor and the dated signature of the study director. Statistical method to be used.

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Documentation:- It is an essential part of quality assurance . Clear and précised documents prevent errors that can occur due to oral communications and permit traceability. Document should be legible and error free. Some important documents are:- Site master file, Quality manual , Standard operating procedures , Manufacturing formula , Batch record , Specification etc.

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Following are the essential properties of documents:- 1.Documents should be prepared , reviewed and distributed with care after approval with signature and date by appropriate and authorized persons. 2.Document contents should be clear, the title, purpose and nature of documents should be mentioned. 3. Reproduction of documents should provide error free copies.

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4. documents should be reviewed at defined intervals or whenever considered necessary. 5. document revision system should provide for clear differentiation between recontent and superseded versions. 6. Alterations to entries, if any should permit reading of original entry, should be signed and dated and the reason mentioned where appropriate.

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7. records should be made or completed at all stages of manufacture so as to ensure traceability. 8. records should be retained for at least one year after the expiry date of the finished product. 9. wherever data is maintained through electronic or photographic systems, defined procedures should be followed and accuracy of records checked.

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Common data that every document should contain is shown in the format. Company name & title of document Identification number Issued date, effective date & review date Page number in manner of X of Y, history & reference. Prepared by, checked by & authorized by

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Data generation and starage (Records):- Storage facility for records should reflect the need to preserve confidentially, integrity and logical retrieval. Thought should be given to the susceptibility of the records to damage from fire (heat), flood (humidity), electric or magnetic fields, dust, solvents etc. Purpose:- The purpose of this procedure is to describe the requirements for the retention of laboratory documentation under GMP and the disposal of such documentation.

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Scope:- It is the resposibility of laboratory staff to ensure all relevant documentation is kept for the specified timeframes and to archieve large quantities of documentation that is to be kept long term but not necessarily looked at on a regular basis.

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Retention and disposal of laboratory documentation:- The laboratory procedure a large quantity of documentation which must be clearly labeled stored and accounted for at all times for the duration of the documents retention period (minimum 13 year) Documents are stored in either in laboratory safes or in the numbered well boxes with detailed reference. Archiving system is predominantly manually hand recorded system for recording of documentation and can only be traced by manually looking through logbooks to find information. All analytical laboratory documentation is to be kept for a minimum of 13 years (unless otherwise stated ). If in doubt about what documentation must be retained, ask the laboratory manager or the QA manager. Documents must be disposed of by shredding or incineration.

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COMMONLY RECORDED LABORATORY DOCUMENTATION: Faculty/rejected Material Reports Finished good certification of analysis : Each batch is assigned a pre numbered certificates of analysis known as lab number… all tests and results are to be printed on the certificate of analysis. Finished good Register : All manufactured finished good products are entered into the finished good register which records the following information: lab no. (pre printed number on the top of the finished good certificate of analysis), product name, code no., Manufacture date , container , batch size, comments , goods booking slip no , QA signature and date of when product was passed. Raw material certificates of analysis : incoming Raw materials are all assigned a certificate of analysis, which was generated from an entry in the raw material register. All tests and result are to be printed on the certificate of analysis.

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RETENTION SAMPLES:- DEFINATION: A sample from every batch of product made and the chemicals and components that make up a finished good are kept for a set period of time for use as reference material should be a problem with a specific product or batch.

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CONDITIONS WHICH RETENTION SAMPLE MUST MEET:- The sample shall consist of at least twice the quantity necessary for all tests required to determine its compliance with specification. The sample shall be stored in controlled room temperature expect where the product labeling or specification states otherwise. The sample shall be stored in the same primary container enclosure system in which the product is marked or shipped, or in one that has essentially the same characteristic. The sample shall be securely stored in accordance with their labels requirements and segregated from other material. The conditions in the store area must be supervised and recorded.

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The storage area shall be supervised by appointed responsible person from quality assurance. Access shall be restricted to authorized personnel only. Whenever a retention sample is required for repeated testing ,etc. It can only be released from the store following a written order approvable an authorized person, e.g. QA manager. An inventory list of stored sample sample shall be kept. Any released or discarded sample must be recorded. Samples found to comply with the specification should be kept for atleast 6 months. Those that do not should be kept for atleast 1 year, or any longer period specified in current regulations.

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FINISHED GOODS RETENTION SAMPLE:- ● Retention samples are to be individually marked with ‘R/S’. ● Small boxes are to be held together in bundles of 4 or 5 with sticky tapes. ● Use standard size well boxes for all products, which can be ordered through the warehouse. ● Each well box is to be given a number that is unique and distinguishes it from all other well box. Must contain ‘R/S’ followed by 4 digit number. The 6 digit name is entered into “RETENTION SAMPLE REGISTER LOG”

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● Samples are packed into shipper collected from warehouse. ● Once the well box if full of shippers, the front panel must have the well box number and date to be discarded. These are to be written as large and legible as possible. ● The ‘Date to be discarded ‘ is obtained by reviewing the “Retention Sample Register Log” and determining the longest/last expiry date. Then add one year to this date and that is the month and year for the discard date.

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RECORDS:- Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch.

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EQUIPMENT CLEANING AND USE LOG:- A written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed. If equipment is dedicated to manufacture of one product, then individual equipment logs are not required, provided that lots or batches of such product follow in numerical order and are manufactured in numerical sequence. In cases where dedicated equipment is employed, the records of cleaning, maintenance, and use shall be part of the batch record. Copyright 2001 by Marcel Dekker, Inc. All Rights Reserved. The persons performing and double-checking the cleaning and maintenance shall date and sign or initial the log indicating that the work was performed. Entries in the log shall be in chronological order.

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CLOSURE, AND LABELING RECORDS:- These records shall include the following: (a) The identity and quantity of each shipment of each lot of components, drug product containers, closures, and labeling; the name of the supplier; The supplier’s lot number(s) if known; the receiving code and the date of receipt. The name and location of the prime manufacturer, if different from the supplier, shall be listed if known. (b) The results of any test or examination performed (including those performed derived therefrom .

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An individual inventory record of each component, drug product container and closure and, for each component, a reconciliation of the use of each lot of such component. The inventory record shall contain sufficient information to allow determination of any batch or lot of drug product associated with the use of each component, drug product container and closure. Documentation of the examination and review of labels and labeling for conformity with established specifications. (e) The disposition of rejected components, drug product containers, closure, and labeling.

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MASTER PRODUCTION AND CONTROL RECORDS:- The master manufacturing records should clearly identify: 1. Name of product, product type, strength 2. Ingredients to be added: name, alphanumeric code, amounts or dosage unit or percentage 3. Amount of each ingredient for a batch 4. Sequence of adding ingredients 5. Equipment to be utilized designated by name and, where appropriate, by number 6. Processing steps with details of conditions such as time, temperature, speed 7. In-process samples, testing, acceptance criteria 8. Special precautions and hazardous conditions which exist and the necessary safety equipment to be used 9. Theoretical yields and actual yields (action levels) 10. Space for signature and date of operator/supervisor performing or checking each significant step .