Do not use original container as drying vessel for drying. If analytical standard is required to be dried before use, take a cleaned and dried weighing bottle for drying.During use, after opening the analytical standards, it needs to be closed tightly with the Parafilm or Aluminum Crimp Cap shall be kept in the upright position in respective cabinet by authorized person.For weekly off/ holiday, temperature record shall be verified on subsequent working day. Temperature record for the working standard storage cabinet shall be verified on daily basis.If the potency of Analytical Standard is grater than 100%, it shall be considered as 100% for the calculation.When working standard is quantity is consumed before its validity period, new working standard can be prepared using the current lot of reference standard. ![]() Before using and weighing of the reference standard or working standard, place the standard vial in the Desiccator OR Tray provided to attain the room temperature or as per the requirement.In case any abnormality observes such as, wrong standard issued, Lot no., working standard is not within the validity period, do not use the vial and inform to laboratory support team person.At the time of usage, analyst shall ensure the correctness of the standard vial against the specification like name of the standard, lot number and validity period.Once the vial is opened, it shall be discarded after the analysis is completed and report is reviewed if there is no out of specification or laboratory event observed. For every new analysis use the fresh working standard vial.After weighing do not transfer the remaining quantity into the original container. For the liquid standards, transfer the material into the clean and dry glassware.After completing the weighing activity, remaining quantity of working standard shall not be transfer into the original container.During handling of analytical standards, wear Personal Protective Equipment (PPE) such as hand gloves, safety goggles, and nose mask as applicable.The list shall be updated on need based which shall be authorized by Head Quality Control Laboratory (Head QC).Accessed to Analytical standards shall be done authorized personnel as per the List of authorized personnel displayed at the Analytical standards storage room/ cabinet. ![]() Secondary Reference Standards are also called as Working Standard. Working standard/ Secondary reference standard: Secondary Reference Standards OR Working Standard are the standards that are Qualified against the current lot of the Reference Standard. In-House Reference standard: These are authentic substance, Characterized and verified In-House and suitable for their intended purpose. ![]() Pharmacopoieal Reference standard: These are authentic Substance of high purity with Critical characteristics and Suitable for their intended purpose supplied by the official Pharmacopoieal sources. Head-QC/ Designee: Ensure the Compliance of the SOP. Section Head-QC: Review the qualification report. Laboratory Supervisor: Review of Qualification report QC-Personnel: Receipt, qualify, handle and destruction after use of analytical standards The scope of this SOP is to Procure, Qualify, Store, Handle and Disposal of Reference Standards, Secondary Reference Standard OR Working Standard, Gas Chromatography Standards used in the Quality Control Laboratory for analysis at. To lay down a procedure for Receipt, Qualification and Handling of Analytical Standards. Standard Operating Procedure for Receipt, Qualification and Handling of Analytical Standards. SOP for Receipt, Qualification and Handling of Analytical Standards
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |