PowerPoint Presentation: 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

PowerPoint Presentation: 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

PowerPoint Presentation: 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 .

PowerPoint Presentation: 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.

PowerPoint Presentation: 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.

PowerPoint Presentation: 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

PowerPoint Presentation: 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 its 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

PowerPoint Presentation: 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 Oct09 Ph 07 Ph 04 Date by Done by Remark

PowerPoint Presentation: 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

PowerPoint Presentation: UNIQUE PHARMACEUTICALS TEPERATURE & RELATIVE HUMIDITY RECORDS Department : Q.C. lab Month : oct09 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)

PowerPoint Presentation: 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.

PowerPoint Presentation: 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.

PowerPoint Presentation: 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

PowerPoint Presentation: 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.

PowerPoint Presentation: 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.

PowerPoint Presentation: 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.

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

PowerPoint Presentation: 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:

PowerPoint Presentation: 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.

PowerPoint Presentation: 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.

PowerPoint Presentation: 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.

PowerPoint Presentation: Documentation:- It is an essential part of quality assurance . Clear and prcised documents prevent errors that can occur due to oral communications and permit traceability. Document should