To lay down the procedure to withdrawal, storage, observation & destruction of control sample from production (Oral & Injectable), Q.C. (R.M. Retention).
This Standard Operating Procedure is applicable for withdrawal, storage, observation & destruction of control sample from production (Oral & Injectable), Q.C. (R.M. Retention) of pharmaceutical formulation plant.
3.1 QA/QC officer or above is responsible for withdrawal, storage, observation & destruction of control sample.
QA Head shall be accountable for implementation of this SOP.
5.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QA : Quality Assurance
6.1 Withdrawal of Control Sample
6.1.1 Control sample shall be withdrawn from each batch of product manufactured.
6.1.2 Quantity of sample shall be withdrawn as per Table-I
|S.No.||Sample||Quantity of sample drawn (in Unit)|
|3||Dry Syrup (Bottles)||44|
|4||Dry Powder injection (Vials)||128|
6.1.3 The QA Officer shall collect the finished product control sample from each batch throughout packing operation as per quantity mentioned in the table-I and make the entry in finished product control sample logbook as per Annexure No.-I
6.1.4 For Raw Material retention sample, the QC personnel shall collect the sample and make the entry in raw material retention sample logbook as per Annexure No.-II
6.1.5 Control Sample sticker label shall be stick on each pack as per Annexure No.-III
6.1.6 The control sample shall be proportionately representing from all different pack size in same batch sales / Physician sample’
6.1.7 Liquid and solvent are not retained in control sample room.
6.2 Storage of control sample
6.2.1 The control sample shall be stored at temperature NMT 25° C.
6.2.2 The record of temperature monitoring of control sample room shall be maintained as per “SOP on monitoring of temperature and relative humidity”.
6.3 Physical observation of control sample
6.3.1 Physical observation will be carried out after every six month and the observation records will be maintained as per the Annexure No.-V
6.3.2 During physical observation following points shall be considered where ever applicable but not limited to:
Appearance/Description, Packing Quality, Imprinting, Overprinting, Intactness of package, delamination, Peeling/Motting of coated tablets.
6.3.3 In case, quantity of control sample / retention sample is required for testing / reference purpose, the same shall be issued only after the approval of the request as per the Annexure No.-IV, such withdrawal shall be recorded in ‘Finished product control sample logbook’& ‘Raw material retention sample logbook ‘as per Annexure No.-I & Annexure No.-II respectively.
6.4 Destruction of control sample
6.4.1 Control sample & Retention sample shall be destroyed after one year of expiry date. For destruction of control sample refer ‘SOP on destruction of drugs products and its components’.
6.4.2 Destruction record of finished product control sample & raw material retention sample will be maintained in ‘Finished product control sample logbook’ as per the Annexure No.-I & ‘Raw material retention sample logbook ‘as per Annexure No.-II
7.0 Forms and Records (Annexures)
7.1 Finished product control sample logbook – Annexure-I
7.2 Raw material retention sample logbook – Annexure-II
7.3 Control Sample Sticker Label – Annexure-III
7.4 Control Sample/Retention Sample Requisition Slip – Annexure-IV
7.5 Physical observation of Control sample – Annexure-V
8.1 Master copy – Quality Assurance
8.2 Controlled copies- Quality Assurance, Production, Quality Control & Warehouses RM
|Date||Revision Number||Reason for Revision|