Quality control laboratory by shreyas

Responsibilities, Routine Control Instruments And Reagents Used In QUALITY CONTROL LABORATORY: 

Responsibilities, Routine Control Instruments And Reagents Used In QUALITY CONTROL LABORATORY Prepared by: Shreyas goswami, Guided by:Dr . Ujash A. Shah, M.pharm. (Q.A.), Associate Professor, 1 st sem. Dept. of Q.A. NOOTAN PHARMACY COLLEGE, VISNAGAR. 1

Quality control:: 

Quality control: Quality control deals with the system which accepts or rejects any activities or parameter which affects the quality of product and thus prevent quality deficiency. Quality assurance: It is a system which assure that the overall activities in the laboratory are being performed as designed by particular standards. 2

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Quality System Quality Assurance Quality Control

The Pyramid Of Control: 

4 The Pyramid Of Control

The PDCA cycle:(Plan Do Check Act): 

The PDCA cycle:(Plan Do Check Act) Step 1 Step 4 Step 3 Step 2 Fig.1 PDCA cycle PDCA

Definition of Q.C. by WHO: 

Definition of Q.C. by WHO “Q.C. is the part of GMP concerned with sampling, specification, and testing and with the organization, documentation and release procedure which ensure that the necessary and relevent tests are actually carried out and those materials are not released for use, nor product released for sale or supply, untill their quality has been satisfactory. Q.C. is not confined to only laboratory operation but must be involved in all decisions, concerning with the qaulity of the product”. 6

WHO guidelines for Q.C.laboratory: 

WHO guidelines for Q.C.laboratory Q.C. laboratory should be seperated from production areas. Areas where biological, microbiological or radioisotope test methods are employed should be seperated from each other. Control laboratory should be designed to suite the operations to be carried out in them. There should be adequate suitable storage space for samples, reference standards and records. 7

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The design of the laboratories should take into account the suitability of construction materials, prevention of fumes, and ventilation. A separate room may be needed for instruments to protect them against electrical interference, vibration, contact with excessive moisture and other external factors. Samples of starting materials, packaging materials, intermediate products, bulk products and finished products must be taken by methods and personnel approved by Q.C. department. 8

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Test methods must be validated. Record must be made. No batch of product is to be released for sale or supply prior to certification by the authorized person from Q.C. dept. Sufficient sample of starting materials and product must be retained to permit future examination of the product if necessary. 9

MCC south Africa Guidelines:: 

MCC south Africa Guidelines: Adequate standards and reagents are maitained. The finished product complies with the legal requirements and is enclosed within its specified containers and correctly labelled. Q.C. laboratory should be under the authority of a person with appropriate qualification and experience. All relevant quality control staff should be suitably educated. 10

Responsibilities:: 

Responsibilities: Study Director’s Responsibilities 1. The Study Director has the responsibility for the overall conduct of the study and for its final report. 2. These responsibilities should include, but not be limited to, the following functions. 11

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The Study Director should: a) Approve the study plan and any amendments to the study plan by dated signature. b) Ensure that the Quality Assurance personnel have a copy of the study plan and any amendments in a timely manner and communicate effectively with the Quality Assurance personnel as required during the conduct of the study. c) Ensure that study plans and amendments and Standard Operating Procedures(SOP s) are available to study personnel. 12

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d) Ensure that the procedures specified in the study plan are followed, and asscess and document the impact of any deviations from the study plan on the quality and integrity of the study, and take appropriate corrective action if necessary. e) Ensure that all raw data generated are fully documented and recorded. f) Ensure that computerised systems used in the study have been validated. 13

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g) Sign and date the final report to indicate acceptance of responsibility for the validity of the data and to indicate the extent to which the study complies with these Principles of Good Laboratory Practice. h) Ensure that after completion (including termination) of the study, the study plan,the final report, raw data and supporting material are archived. 14

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Principle Investigator’s responsibilities: The principle investigator will ensure that the delegated phases of the study are conducted in accordance with the applicable principles of Good Laboratory Practice(GLP). 15

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Study personnel’s responsibilities 1. All personnel involved in the conduct of the study must be knowledgeable in those parts of the principles of Good Laboratory Practice which are applicable to their involvement in the study. 2. Study personnel will have access to the study plan and appropriate Standard Operating Procedures applicable to their involvement in the study. It is their responsibility to comply with the instructions given in these documents. Any deviation from these instructions should be documented and communicated directly to the Study Director, and/or if appropriate, the Principal Investigator(s). 16

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3.All study personnel are responsible for recording raw data promptly and accurately and in compliance with these Principles of Good Laboratory Practice, and are responsible for the quality of their data. 4.Study personnel should exercise health precautions to minimise risk to themselves and to ensure the integrity of the study. They should communicate to the appropriate person any relevant known health or medical condition in order that they can be excluded from operations that may affect the study. 17

Instruments:: 

Instruments: Definition ‘A device which is used to test, observe, measure, generate or record the characteristics known as instrument.’ vaccum oven HOT AIR OVEN Karl fischer appuratus 18

MCC South Africa guidelines:: 

MCC South Africa guidelines: Separate room may be necessary to protect sensitive instruments from vibration, electrical interference, humidity etc. Instruments should be appropriate to the testing procedure undertaken. Instruments should be calibrated at suitable specified intervals and rapidly available records for each instruments or a piece of equipment. 19

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Written standard operating procedure should be readily available for each instrument. There should be a ‘calibration master plan’ for the instruments used in Q.C. laboratory. A Red, Orange, Green colour coding may be used to indicate; Red for equipment out of order, do not use. Orange for equipment requires attention, may be used with necessary precautions. Green for equipment is in working condition. 20

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Commonly used instruments In Q.C. lab. Gas chromatography HPLC Capillary electrophoresis U.V. spectrophotometer I.R.spectrophotometer Analytical balance Karl fischer titrator Hot air oven Vaccum oven pH meter Dissolution test apparatus Disintegration test apparatus Polarimeter etc. 21

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It is the action of proving that any equipment works correctly and actually leads to accurate and reliable results. It includes installation qualification and operational qualification . Installation Qualification(I.Q.): Establishes that the instrument is delivered as designed and specified, that it is properly installed in the selected environment and the environment is suitable for the operation and use of the instrument. 22 What is Qualification?

Operational qualification(O.Q.):: 

Operational qualification(O.Q.): The process of demonstrating that equipment will function according to its operational specification in the selected environment. What is Calibration? Calibration is the process of establishing how the response of a measurement process varies with respect to the parameter being measured. 23

What is Traceability?: 

What is Traceability? Traceability is the property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibration, each contributing to the measurement uncertainty. 24

Operational qualification test:(O.Q. test): 

Operational qualification test:(O.Q. test) GC - peak retention time. -peak area precision. Capillary electrophorosis - voltage stability. U.V.spectrophotometer - wavelength accuracy. - wavelength resolution. 25

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Analytical balance -calibration. Dissolution test apparatus - temperature accuracy. -accuracy of shaft rotation. - control of distance of shaft to side of vessel. 26

Maintenance:: 

Maintenance: Maintenance is also carried out on the bases of O.Q. test, so it gives idea about the components that are subject to wear and require routine replacement. Preventive maintenance is the most cost effective method of maintaining equipment when requires frequent services. 27

Reagents:: 

Reagents: Basic requirement: Reagents should be prepared as per the pharmacopoeia or other authorised book. The reagents, after their preparation should be labelled properly. The lable should include, - concentration; -shelf life; -storage condition; -signature of a person who prepared it and date of preparation; 28

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In large laboratories separate rooms may be provided for flammable substances and self igniting materials like Na+, K+ etc. Responsibility of reagents should be clearly assigned. Reference substance: Reference substance have high purity and critical characteristics . Reference substances are maintained and distributed by national laboratory of government. 29 Whenever recommended, reagents should be prepared fresh.

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Reference substance should be stored: -in dry place; -away from heat; -protected from light. 30

References:: 

References: Potdar M.A, cGMP (Current Good Manufacturing Practice), PharmaMed Press, First Edition, Page; 69,171-180. Sharma P.P, GLP(Good Laboratory Practice),Page; 36, 37 Kenneth W. sigvardson et al, Laboratory equipments qualification, Article. Joseph M. Juran, Juran’s quality handbook, 5 th edition, section 4. 31

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Thank You 32