Purpose
This SOP describes
the procedure for receipt, storage and Handling of Reference
Standards procured
from various drug authorities like BP/EP and USP.
Scope
This procedure is applicable
for receipt, storage and Handling of Reference Standards at ABC Limited.
Procedure:
Precautions
- Ensure the availability of clean and dry amber color vials before transferring Reference Standard.
- Reference Standard shall be stored at temperature, humidity specified on the container label and protected from light.
- Other products shall not contaminate contents of Reference Standard vial or any spillage
should not occur.
- Reference Standard vials shall be immediately sealed after use.
Reference standards are classified as:
Pharmacopoeial
Reference Standard:
These
are for the products mentioned in the Pharmacopoeia i.e. USP, BP, Ph. Eur and
Indian pharmacopoeia.
Non
Pharmacopoeial Reference Standard:
- These are for the products, which are not mentioned in the Pharmacopoeia.
- Procurement and storage of reference standards:
- Pharmacopoeial Reference Standards shall be procured from the authentic sources.
- Non Pharmacopoeial Reference Standards are produced from the manufacturer of specific substance or shall be provided by authentic sources with COA.
- Reference Standard shall be procured whenever:-
- New lot number of Pharmacopoeial Reference Standard is released by
- regulatory agencies.
- Non-Pharmacopoeial Reference Standards shall be procured in its expiry date.
- When new product is introduced in the facility.
- Existing stock of Reference Standard is spoiled or consumed.
- Purchase requisition shall be raised by Analyst for the desired “Reference Standard” to be procured and shall be authorized by In-charge.
- Reference Standard (Non-Pharmacopoeial) shall be received from manufacturer along with copy of certificate of analysis and supporting data.
- On receipt of Reference Standard a copy of GRN and delivery challan or voucher copy shall be filed for ready reference.
- On receipt check the integrity of seal and label details.
- In case of failure to comply with integrity of vial or appearance of material, inform to purchase department for necessary action.
- Record the detail in the Reference Standard logbook .
- Whenever the potency/purity is not mentioned on the label consider the same as100 %.
- The impurity standards solutions shall be stored between 20C – 80C.
Usage & destruction of reference
standards:
- Record the date of opening for the testing or for the Qualification of Working Standard in Reference Standard logbook
- During usage of Reference Standard, precautions should be taken such that contents of the vial are not contaminated with other products.
- Seal the Reference Standard vial after usage & keep in the designated place.
- Usage duration validity of impurity standard shall be determined against approved impurity standard. If the Reference Standard is expired (for Non-Pharmacopoeial) and/ or replaced (for Pharmacopoeial) by a new lot to Reference Standard dispose of the previous lot by dissolving in a suitable solvent and discarding the solution.
- In case Reference Standards are not available with the location it shall be procured from authentic source.
- In case, the Reference Standard is not available with the above mentioned, and then the Working Standard shall be prepared by analyzing the sample from FDA approved external agency.
