SOP for collection and handling of QP samples during packing operation
1.0 OBJECTIVE:
To lay down the procedure for collection and handling of QP (Qualified Person) samples during packing activity.
2.0 SCOPE:
The scope of this document is to describe the procedure for collection and handling of QP samples during packing operation for each batch of all EU Dossier Products manufactured at [Company name].
3.0 RESPONSIBILITY:
IPQA Personnel – To withdraw the QP Samples.
Head QA – To ensure the compliance of this SOP.
4.0 PROCEDURE:
4.1 Collection of QP samples (Blister/Strip pack)
4.1.1 Withdraw the QP sample from the packing line during packing operation from each batch of all EU Dossier Products.
4.1.2 Withdraw minimum 250 tablets in two set (without breaking the pack or blister/strip) at different intervals on line preferably at “START”, “MIDDLE” and “END” of packing operation.
4.1.3 Affix the sticker as “START” (Green Colour), “MIDDLE” (Blue Colour) and “END” (Maroon Colour) on the show box / cartons respectively as per the time of collection. Collected sample shall be kept in the Lock and Key.
4.1.4 Carry out shrink packing or keep in poly bag of above two sets of samples segregated as “START”, “MIDDLE” and “END” separately. Affix the sticker as “QP SAMPLE” on the both the shrink-wrap or poly bag.
4.1.5 Keep both shrink wrap or poly bag in sample box marked/labeled as “QP SAMPLE FOR ANLYSIS”. Also affix one shipper label on this box bearing batch details and finally seal the box with with BOPP tape
4.1.6 Enter the details of the “QP SAMPLES” in the Daily Packing Slip of respective packed goods. Record the details of QP sample in QP sample register as per Annexure II
4.1.7 Send the sample box to Finished Goods Store during transfer of Finished product.
4.2 Collection of QP samples (Bulk Pack)
4.2.1 Withdraw the QP sample from the packing line during packing operation from every batch of all EU dossier products.
4.2.2 Withdraw approximately 250 tablets in two set at different time intervals during on line packing operation.
4.2.3 Collect the bulk tablets pack during “START”, “MIDDLE” and “END” of packing and keep them in the sample poly bags separately. Collected sample shall be kept in Lock and key.
4.2.4 Seal each poly bag and affix the sticker as “START”, “MIDDLE” and “END” along with “QP SAMPLES” on the individual poly bags.
4.2.5 Keep the sealed poly bags in the individual plastic container and affix sticker as “QP SAMPLES” on the respective individual plastic containers.
4.2.6 Affix the sticker label indicating Product Name, Batch No., and sampling quantity on the individual plastic containers as per annexure III
4.2.7 Keep individual containers of “START”, “MIDDLE”, “END” in the sample box marked as “QP SAMPLES FOR ANALYSIS”.
4.2.8 Affix one shipper label of the concerned batch on the sample box and seal with BOPP tape.
4.2.9 Enter the details of the “QP SAMPLES” in the Daily packing slip of respective packed goods Record the details of QP sample in QP sample register as per Annexure II
4.2.10 Send the sample box to Finished Goods Store.
5.0 ANNEXURE (S):
Annexure I Specimen Stickers [sample not provided]
Annexure II QP sample register
Annexure III Specimen Label for Plastic Container [sample not provided]
Annexure II QP sample register
Product Name:
Product Code:
Sr. No.
Date
Batch No.
Mfg. Date
Exp. Date
Packing Style
Collected at
QP Sample Quantity
Collected By