Friday, November 26, 2010
Selection, Standardization and Storage of reference and working standards
1.0 Purpose : To provide instructions for selection, standardization and storage of reference and working standards.
2.0 Objective : To provide documented procedures for selection, standardization and storage of reference and working standards.
3.0 Scope : This procedure is applicable for selection, standardization and storage of reference and working standards in QC Department.
4.0 Responsibility :
§ Primary : QC Chemist
§ Secondary : Overall QC Officer
5.0 Procedure :
· Selection and Storage of Reference Standards.
Ø Reference standard/substance RS are issued by the respective Pharmacopoeia Commission.
Ø They are the official standards.
Ø Select current lots of the reference standards.
Ø Store them in suitable container (e.g. desiccators) moisture free atmosphere under temperature-controlled condition.
Ø Maintain records for reference standard in respective logbook.
· Selection, Standardization and Storage of Working Standards.
Ø Working Standard shall be used for routine analysis.
Ø Working standards should be standardized at regular intervals against the reference standards.
· Procedure for Raw Materials working standards.
Ø Working standards are selected from amongst the raw materials received and approved by the QC.
Ø The selected raw material’s working standards having high purity or negligible impurities and low moisture content.
Ø For solvent working standard shall be used from any reputed external manufacturer, pure grade materials with certificate of analysis.
Ø Selected raw material working standard shall be re-tested and note down the observations in respective worksheet.
· Procedure for Intermediates and Finished Products working standards.
Ø Selected intermediate and finished product working standards can be prepared by
repeated crystallization in suitable solvents.
Ø These working standard having high purity or negligible impurities and low moisture / loss on drying content.
Ø R&D and QA should authorize procedures for the preparation of intermediate and finished products working standard.
Ø Approved methods should be used for the preparation of working standard.
Ø Working standards should be standardized at regular intervals against the reference standards or previous working standards.
Ø Frequency of standardization: Once in a Year.
Ø Standardization should be done in triplicate analysis.
Ø Loss On Drying / Moisture content and Assay tests parameters taken for standardization.
Ø The average value should be reported.
Ø Note down the observations in respective worksheet. And maintained relevant graphs in respective working standard file.
Ø Re-standardization shall be done within + 15 days from the said date.
Ø Bottle of working standards should be stored in a desiccators having activated silica gel, and kept at controlled temperature.
Ø Information on status label includes name of material, working standard batchnumber, purity, LOD / moisture content, date of preparation, valid up to etc.
· Storage of working standards.
Ø After standardization the working standard is divided into equal quantities
Ø (Approx – 2 to 10 gm each) and filled appropriate vials / bottles (minimum 2 to 4). Vials should be cleaned and dried.
Ø Each vial/bottle is to be used for three months from the date of opening and then discarded. Open on date shall be mentioned on the label.
Ø The other information of the label includes name of material, open on date, purity, LOD/Water value, and use before date and valid up to.
Ø The bottles are then sealed and kept in desiccators at the prescribed storage condition for the future use.
Ø The temp of the area of storage is maintained and monitored daily.
Ø The last bottle is kept for use as a reference std. during next standardization. Reference standard to be re-validated every year.