1.0 OBJECTIVE
1.1 To lay down a procedure for handling of Preparation and Handling of working standard and Handling of Reference Standards.
2.0 SCOPE
2.1 This procedure applies to the Pharmaceutical Manufacturing Facility of ________________________________________-
3.0 RESPONSIBILITY
3.1 Chemists – Quality Control
4.0 ACCOUNTABILITY
4.1 Head – Quality Control
5.0 PROCEDURE
5.1 Reference Standards are categorized into three types
5.1.1 Pharmacopoeial Reference Standard: For the products mentioned in the respective catalog of Pharmacopoeia (Pharma forum) USP/ BP/ IP.
5.1.2 Non-Pharmacopoeial Reference Standard: These are for the products, which are not mentioned in the Pharmacopoeia or products for which pharmacopeia reference standards are not available.
5.1.3 Working Standard (WS): Working standards are developed in-house and qualified against the Reference Standard.
5.2 Procurement and storage of Reference Standard
5.2.1 Pharmacopoeial Reference Standards are procured from the respective Pharmacopoeial agencies.
5.2.2 Non-pharmacopoeial Reference Standards are procured from the vendor of those materials. Non-pharmacopoeial reference standard from Vendor along with its COA and relevant characterization data.
5.2.3 For compendial products use the Pharmacopeial reference standard as the primary standard. Non-compendial products use Vendor standards as a primary standard (Maintain the consumption record ).
5.2.4 Reference Standards are procured whenever
5.2.4.1 New lot number of the pharmacopoeial reference standard is released by the pharmacopoeial agencies or as and when required.
5.2.4.2 Non-pharmacopoeial reference standard is expired.
5.2.4.3 New product is introduced in the facility.
5.2.5 Keep track of the emergence of a new lots number of reference standards in the publications of pharmacopoeial agencies or on the website of respective pharmacopoeial agencies.
5.2.6 After receiving the reference standard, record the details in the reference standard logbook as per Annexure: 1.
5.2.7 On receipt check the integrity of the seal of the reference standard vial/Bag and label details.
5.2.8 Reference standard label should include the name of the standard, traceability reference number (Lot #), and source.
5.2.9 Store the reference standard vial in the well-closed box and keep it in the fridge at a temperature of 5° ± 3°C.
5.3 Usage & Destruction of Reference Standard
5.3.1 Record the quantity used for the testing or for the Qualification of working reference standard in the reference standard logbook. And keep the accountability of reference standard quantity.
5.3.2 During usage of the reference standard, precautions should be taken such that the contents of the vial are not contaminated with other products and any spillage should not occur.
5.3.3 Take the required WS vial from the box, which is kept in the fridge at 2-8°, and keep it in the desiccator for about 15 to 20 minutes to attain room temperature.
5.3.4 Seal the reference standard vial after usage & keep it in the designated place.
5.3.5 Ensure that the reference standard quantity is sufficient for the next qualification. If not indent for further procurement.
5.3.6 If the reference standard is expired (for nonpharmacopoeial) and/or replaced (for pharmacopoeial) by a new lot of reference standard, destroy the previous standard by dissolving it in a suitable solvent and discarding it.
5.3.7 Record the destruction in the reference standard log.
5.4 Qualification of working standards
5.4.1 Pharmacopoeia reference standard is received in less quantity therefore working standard is qualified against the Pharmacopoeial reference standard.
5.4.2 If non Pharmacopoeial reference standards are received in sufficient quantity same standard can be used for routine analysis, otherwise working standard is qualified
5.4.3 For qualification of WS, select one approved manufacturing batch, tested as per respective pharmacopeia, which has the highest purity under the acceptable range.
5.4.4 Collect approximately 50 gm sample from the approved batch recently manufactured.
5.4.5 Perform the following test.
5.4.5.1 Description.
5.2.5 Keep track of the emergence of a new lots number of reference standards in the publications of pharmacopoeial agencies or on the website of respective pharmacopoeial agencies.
5.2.6 After receiving the reference standard, record the details in the reference standard logbook as per Annexure: 1.
5.2.7 On receipt check the integrity of the seal of the reference standard vial/Bag and label details.
5.2.8 Reference standard label should include the name of the standard, traceability reference number (Lot #), and source.
5.2.9 Store the reference standard vial in the well-closed box and keep it in the fridge at a temperature of 5° ± 3°C.
5.3 Usage & Destruction of Reference Standard
5.3.1 Record the quantity used for the testing or for the Qualification of working reference standard in the reference standard logbook. And keep the accountability of reference standard quantity.
5.3.2 During usage of the reference standard, precautions should be taken such that the contents of the vial are not contaminated with other products and any spillage should not occur.
5.3.3 Take the required WS vial from the box, which is kept in the fridge at 2-8°, and keep it in the desiccator for about 15 to 20 minutes to attain room temperature.
5.3.4 Seal the reference standard vial after usage & keep it in the designated place.
5.3.5 Ensure that the reference standard quantity is sufficient for the next qualification. If not indent for further procurement.
5.3.6 If the reference standard is expired (for nonpharmacopoeial) and/or replaced (for pharmacopoeial) by a new lot of reference standard, destroy the previous standard by dissolving it in a suitable solvent and discarding it.
5.3.7 Record the destruction in the reference standard log.
5.4 Qualification of working standards
5.4.1 Pharmacopoeia reference standard is received in less quantity therefore working standard is qualified against the Pharmacopoeial reference standard.
5.4.2 If non Pharmacopoeial reference standards are received in sufficient quantity same standard can be used for routine analysis, otherwise working standard is qualified
5.4.3 For qualification of WS, select one approved manufacturing batch, tested as per respective pharmacopeia, which has the highest purity under the acceptable range.
5.4.4 Collect approximately 50 gm sample from the approved batch recently manufactured.
5.4.5 Perform the following test.
5.4.5.1 Description.
5.4.5.2 Identification (IR, UV, and HPLC as specified in the respective specification).
5.4.5.3 Water Content / Loss On Drying.
5.4.5.4 Assay/Potency.
5.4.6 Above tests should be carried out as per the standard testing procedure.
5.4.7 Record the analysis in the working standard test data sheet issued by QA.
5.4.8 In the test of the assay, prepare reference standard solutions and three working standard solutions as per the respective standard testing procedure.
5.4.9 System suitability should be performed as per the respective standard testing procedure and each WS preparation should be injected in duplicate.
5.4.10 Inject six replicate injections of reference standard solution for system suitability and RSD.
5.4.11 The Relative Standard Deviation of the area of replicate injections for system suitability should comply with the respective standard testing procedure.
5.4.12 Calculate the three assay values with respect to the Average area of reference standard solution obtained on an is basis. The RSD of these six assay values should not be more than 0.5%. Take the Average of six assay values as working standard potency.
5.4.13 WS is given a unique serial no. Which is WS/XXX/YYY/ZZ. XXX is the product code, YYY is the serial number and ZZ is the last two digits of the year.
5.4.14 Prepare certificate of analysis along with a required number of labels for the tests performed for the qualification of WS. Check the contents on the label with respect to the raw data.
5.4.15 Preserve the working standard in clean & dry vials.
5.4.16 Transfers the WS into 6 vials.
5.4.17 Each vial should be properly sealed and labeled.
5.4.18 The remaining quantity is kept in one vial and labeled. If WS is required by any customer, this material can be used.
5.4.19 Keep all the vials in a box and keep them in a 2-8°C refrigerator (Note: Temperature of the fridge should be monitored)
5.4.20 Development of WS to be logged in reference standard log.
5.5 Usage and destruction of WS
5.5.1 One vial shall be issued by the HOD, QC to the analyst for its use for not more than 3 Months.
5.5.2 Issuance of WS vial shall be recorded in the working standard logbook.
5.5.3 Take the required WS vial from the box, which is kept in the fridge at 2-8°, and keep it in the desiccator for about 15 to 20 minutes to attain room temperature.
5.5.4 After attaining room temperature weigh the required quantity of the WS and seal the vial immediately and keep it in the designated place of the fridge at 2-8°C. Record the vial taken out time and in time.
5.5.5 Remaining quantity (if any) of the issued vial at the end of 10 days is to be destroyed by dissolving in a suitable solvent & thereafter discarding the solution.
5.5.6 Destroy all remaining amount of WS as per the procedure mentioned in 5.5.3 at the end of the validity period and after the development of the new WS.
5.5.7 Record the destruction in the reference standard log book.
5.5.8 Frequency of WS development
5.5.8.1 Validity period of WS is yearly. New WS is to be developed within the validity period of the previous WS.
6.0 ABBREVIATIONS
6.1 USP – United States Pharmacopoeia
6.2 BP – British Pharmacopoeia
6.3 EP – European Pharmacopoeia.
6.4 IP – Indian Pharmacopoeia.
6.5 WS – Working Standard.
6.6 QA – Quality Assurance.
6.7 COA – Certificate of Analysis.
6.8 HOD – Head of the Department.
6.9 RSD – Relative Standard Deviation.
7.0 REFERENCES
7.1 Nil.
8.0 ANNEXURES
NIL
END OF THE DOCUMENT
5.4.5.3 Water Content / Loss On Drying.
5.4.5.4 Assay/Potency.
5.4.6 Above tests should be carried out as per the standard testing procedure.
5.4.7 Record the analysis in the working standard test data sheet issued by QA.
5.4.8 In the test of the assay, prepare reference standard solutions and three working standard solutions as per the respective standard testing procedure.
5.4.9 System suitability should be performed as per the respective standard testing procedure and each WS preparation should be injected in duplicate.
5.4.10 Inject six replicate injections of reference standard solution for system suitability and RSD.
5.4.11 The Relative Standard Deviation of the area of replicate injections for system suitability should comply with the respective standard testing procedure.
5.4.12 Calculate the three assay values with respect to the Average area of reference standard solution obtained on an is basis. The RSD of these six assay values should not be more than 0.5%. Take the Average of six assay values as working standard potency.
5.4.13 WS is given a unique serial no. Which is WS/XXX/YYY/ZZ. XXX is the product code, YYY is the serial number and ZZ is the last two digits of the year.
5.4.14 Prepare certificate of analysis along with a required number of labels for the tests performed for the qualification of WS. Check the contents on the label with respect to the raw data.
5.4.15 Preserve the working standard in clean & dry vials.
5.4.16 Transfers the WS into 6 vials.
5.4.17 Each vial should be properly sealed and labeled.
5.4.18 The remaining quantity is kept in one vial and labeled. If WS is required by any customer, this material can be used.
5.4.19 Keep all the vials in a box and keep them in a 2-8°C refrigerator (Note: Temperature of the fridge should be monitored)
5.4.20 Development of WS to be logged in reference standard log.
5.5 Usage and destruction of WS
5.5.1 One vial shall be issued by the HOD, QC to the analyst for its use for not more than 3 Months.
5.5.2 Issuance of WS vial shall be recorded in the working standard logbook.
5.5.3 Take the required WS vial from the box, which is kept in the fridge at 2-8°, and keep it in the desiccator for about 15 to 20 minutes to attain room temperature.
5.5.4 After attaining room temperature weigh the required quantity of the WS and seal the vial immediately and keep it in the designated place of the fridge at 2-8°C. Record the vial taken out time and in time.
5.5.5 Remaining quantity (if any) of the issued vial at the end of 10 days is to be destroyed by dissolving in a suitable solvent & thereafter discarding the solution.
5.5.6 Destroy all remaining amount of WS as per the procedure mentioned in 5.5.3 at the end of the validity period and after the development of the new WS.
5.5.7 Record the destruction in the reference standard log book.
5.5.8 Frequency of WS development
5.5.8.1 Validity period of WS is yearly. New WS is to be developed within the validity period of the previous WS.
6.0 ABBREVIATIONS
6.1 USP – United States Pharmacopoeia
6.2 BP – British Pharmacopoeia
6.3 EP – European Pharmacopoeia.
6.4 IP – Indian Pharmacopoeia.
6.5 WS – Working Standard.
6.6 QA – Quality Assurance.
6.7 COA – Certificate of Analysis.
6.8 HOD – Head of the Department.
6.9 RSD – Relative Standard Deviation.
7.0 REFERENCES
7.1 Nil.
8.0 ANNEXURES
NIL
END OF THE DOCUMENT
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