Working standard/ Secondary standard

As in Pharmaguideline SOP, the re-qualification period is defined as 1 year. Is there any reference guideline? Please specify the guideline and its chapter number.

1 Like

Please clarify your question. Which re-qualification are you referring to?

Is it for manufacturing equipment, QC instrument, or utilities such as Water system, Air Handling system, Compressed air, Nitrogen generator, etc.?

1 Like

Dear sir,
I am referring to QC- Working standard re-qualification. Requalification period of working standard is mentioned as 1 year. If you have any reference guideline regarding it, please provide me the details.