Standard Design Criteria/Guidelines for Balance of Plant of Thermal Power Project 2 x (500MW or above) Section- 1 (General) 1-2 The draft standard design criteria/guidelines for balance of plant of thermal power projects was developed in association with NTPC and a copy of the same was uploaded in February, 2010 on CEA web site. (Proposed criterion: tolerance 0.5%, k=3 for class I balances and 1%, k=3 for class II and III balances). least count X 100. Switch ON the balance. A list of previous versions of the calibration guidelines and the differences between the versions can be found here d=0.1 mg)). (Proposed criterion: k = 1Â±0.0001). View all posts by PharmaState Blog. The linearity error of the balance is an absolute value calculated by the difference between the combined mass of all four weights and the sum of the masses from the two sub-sets of weights, divided by 2. 6.9.2 Acceptance Criteria: Deviation: Standard Weight ± 2 x Least Count % RSD: NMT 0.5 % 6.10 If all the parameters fall with the acceptance criteria limit, affix the calibration tag (no. The acceptance criteria shall be defined by each individual OMCL. If these requirements are met, then the balance fulfills the accuracy part of this test. Verification:- Verification of the balance is performed by placing a suitable weight (depending on the type of balance) in the centre of the weighing pan once and comparing the result with pre-defined acceptance criteria. Having Comparable Objectives and Results”; OIML BULLETIN; vol. 71 OIML R111  for terms related to the standard weights,. 10. It is recommended that the weights have approximately 5%, 50% and 100% of the maximum capacity of the balance (or of the maximum weight used on the balance), depending on the type of balance. Estimation of the measurement uncertainty of concentration of solutions prepared in laboratory, Evaluation of MU - Annex 1: Bottom-up approach – Annex 1.2 Estimation of measurement uncertainty for quantitative determination using spectrophotometric method, Evaluation of MU - Annex 1: Bottom-up approach – Annex 1.3 Estimation of the measurement uncertainty for assay using HPLC method, Evaluation of MU - Annex 2: Top-down approach – Annex 2.1 Use of data from validation studies, Evaluation of MU - Annex 2: Top-down approach – Annex 2.2 Use of data from control charts, Evaluation of MU - Annex 2: Top-down approach – Annex 2.3 Use of certified reference materials, Evaluation of MU - Annex 2: Top-down approach – Annex 2.4 Use of data from collaborative studies, Evaluation of MU - Annex 2: Top-down approach – Annex 2.5 Use of data from PTS, Evaluation of MU - Annex 3: Estimation of measurement uncertainty expressed as confidence interval using standard deviation from testing results, Evaluation & Reporting of Results – Core Document, Evaluation & Reporting of Results – Annex 1A: Model Template for Failure Investigation of OOS Results, Evaluation & Reporting of Results – Annex 1B: Responsibilities of the Laboratory Supervisor, Evaluation & Reporting of Results – Annex 2A: Examples of Re-Test Programmes for Quantitative Tests, Evaluation & Reporting of Results – Annex 2C: Re-Test Programmes for Qualitative Tests, Evaluation & Reporting of Results – Annex 2D: Special Considerations for Animal Testing (Verification of OOS Results), Qualification of Equipment - Core document, Qualification of Equipment Annex 1: Qualification of Liquid Chromatography Equipment, Qualification of Equipment Annex 2: Qualification of GC Equipment, Qualification of Equipment Annex 3: Qualification of UV-Visible Spectrophotometers, Qualification of Equipment Annex 4: Qualification of IR Spectrophotometers, Qualification of Equipment Annex 5: Qualification of Automatic Titrators, Qualification of Equipment Annex 6: Qualification of Piston Pipettes, Qualification of Equipment Annex 7: Qualification of Mass Spectrometer, Qualification of Equipment Annex 8: Qualification of Balances, Qualification of Equipment Annex 9: Calibration/Qualification of pH Meters, Qualification of Equipment Annex 10: Qualification of Atomic Absorption / Atomic Emission Spectrometers, Qualification of Equipment Annex 11: Qualification of Analytical Columns, Validation of Computerised Systems - Core Document, Validation of Computerised Systems Annex 1: Validation of Excel Spreadsheets, Validation of Computerised Systems Annex 2: Validation of Complex Computerised Systems, Handling and Use of Non-Compendial Reference Standards in the OMCL Network, Qualification and Requalification of Analysts, General Requirements for Infrequently performed techniques, Interpretation of Screening Results for Unknown Peptides and Proteins by MS Based Methods, Standard ‘Aide-Mémoire’ for the Mutual Joint Audit/Visits of Official Medicines Control Laboratories, 'Aide-Mémoire' for Environmental Conditions & Treatment of Biological Models, VBRN/ OCABR: 3R Issues for method validation and maintenance of competence, Catalogue of EDQM Products & Services 2020, Disclaimer - © Council of Europe 2020 - © photo credit, European Pharmacopoeia (Ph. 6. If the measured slits are too small then, for a selected width, the instrument will have more photometric noise than normal. Periodic and motivated instrument checks Examples of requirements for GC instruments with FID Instrument module Parameter to be checked Typical tolerance limits 1. It is determined from technical data and the external calibration certificate. (Proposed criterion: tolerance 0.5%, k=3 for class I balances and 1%, k=3 for class II and III balances). Therefore, a weighing range must be defined for all balances. Includes index. operational range of use; e.g. calibration laws as the tolerances depend on the scales load carrying capacity. Find out the Correlation coefficient “r2” for each peak at five levels and record in the Calibration Log. Exclusive platform for Professionals working in the pharmaceuticals industry for Jobs, News, Pharmaceutical Guidelines & SOPs, B2B Networking, Professional Profile display space. Minimum weight:- The minimum weight value depends on the type of balance. Deviation NMT +05% of the actual mass value. EDQM Council of Europe, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France, Tel. How to Perform the USP Chapter 41 Test: Repeatability Test: Be sure the balance is warmed up, leveled and calibrated before starting. Related: Calibration of Analytical Balance Weighing Range of Balances: Some manufacturers direct in their operating manual to weigh minimum 1.0 mg on balance having 0.01 mg least count i.e. This page updates when we add calibration of a new instrument. Definition of Validation: USP: “Validation of an analytical procedure is the process by which it is established, by laboratory studies, that the performance characteristics of the procedure meet the requirements for the intended analytical applications.” Â© PharmaState Blog and pharmastate.com | Pharmaceutical Industry Guidelines, SOPs, News, Views & Articles by Industry Experts.Â Articles/SOPs/Compilations/Published Content on pharmastate.blog is protected by Indian & International Copyright Laws. For the latest updates pertaining to this compilation visit the relevant website. The acceptance criteria shall be defined by each individual OMCL. The network is operated by the European Directorate for the Quality of Medicines and Health Care (EDQM) in Strasburg, and its objective is the mutual exchange of information and the elaboration of common guidelines. 11. +33 3 88 41 30 30 / Fax +33 3 88 41 27 71. Put the weight 200 g on the pan and record the weight in Annexure-2. “Calibration and Verification: Two Procedures. MONTHLY CALIBRATION Set the standard weights for various balances based on the capacity of the balance as mentioned in table – I. Effect of spectral slit width on absorbance fluctuation (performed with pure solvents). ity (χ) are sufficiently small, and the balance is calibrated with reference weights of well known mass, the balance can be used to indicate the conventional mass, m c, of a body under conventionally chosen conditions. (Proposed criterion: SD = max 5*d, where d = (actual) scale interval (e.g. 5.5 After few seconds, the display will show 0.00 g. 5.6 If display is not stable, press the TARE key & wait till the display shows 0.00 g. 5.7 Perform internal calibration and in Annexure-II 5.6 For Accuracy 5.6.1 Place 5 gm. (Proposed criterion: RSD = 0.05%). The OMCL is part of the European network of official control laboratories. GMP & Guidelines, Pharma Industry Guidelines. 5.32 Keep records from performed calibration processes. Eur.) (Proposed criterion: linearity error â¤ accuracy of the balances). Record the observations in the balance calibration record. 1. PA/PH/OMCL (16) 17 R - Qualification of GC Equipment p. 3/12 TABLE III Level III. 2386. They are available to download below. 2. Preface and Notes for Use of OMCL Quality Management Documents; Guidelines. Guidelines for Calibration of analytical instruments in pharmaceuticals are published on this blog. Minimum weight:- The minimum weight value depends on the type of balance. A simplified procedure is proposed as follows: A weight of approximately 50% of the maximum capacity of the balance (depending on the type of balance) is weighed at least 10 times and the mean measurement, standard deviation and relative standard deviation are calculated. 82 General considerations The WHO Expert Committee on Speciﬁ cations for Pharmaceutical Products adopted in 1999 the guidelines entitled WHO Good practices for national pharmaceutical control laboratories, which were published as Annex 3 of the WHO Technical Report Series, No. 902, 2002. We do not guarantee the accuracy of this information or any results and the user is advised to take any decision or action on his/her sole discretion & responsibility. Accuracy class Verification scale interval (e) * It is not normally feasible to test and verify an instrument to e < 1 mg due to the uncertainty of the test loads. First, the combined mass of all four weights is weighed and recorded. 9. If the slit width is unacceptable, then reset the slit calibration. Mail us at: email@example.com.