cGMP and Regulatory Updates

1.0 PURPOSE Purpose of this procedure to maintain & establish a documented system for Issue of packaging material from packing material stores. 2.0 SCOPE This procedure is applicable to the issue of packing material at Vital Healthcare. This includes supplied by contact Giver Parties. 3.0 RESPONSIBILITY Store incharge is responsible for implementation of this procedure. 4.0 PROCEDURE 4.1 Preparation And Preliminary Steps a) Ensure the accountability of packaging material approved material slip only. b) This procedure only after receiving the approved material slip only. 4.2 Preparation And Safety Consideration Used only specified packaging material. 5.0 Chronological Activity And Sequence a) Store Officer will Issue the packaging material in presence of Q.A. Officer only. b) Take only approved packaging material an f...

1.0 AIM To provide standard operating procedure for issue of materials from store. 2.0 SCOPE Store Department. 3.0 AREA OF OPERATION Raw Material Store Room. 4.0 RESPONSIBILITY Store Incharge, QA/QC Officer. 5.0 ACCOUNTABILITY QA/QC Officer. 6.0 PROCEDURE 6.1 Ensure cleanliness of dispensing room and equipments required for dispensing. 6.2 Start dispensing procedure only after receiving the authorised requisition slip. 6.3 Check the zero error of the weighing scale. If error is beyond limit then calibrate the balance according to SOP-ST-008 and proceed for weighing only after the balance displays zero. 6.4 Use gloves & mask during dispensing. 6.5 Stores Incharge will dispnese only in presence of Q. A. officer only. 6.6 Clean & wipe out every container with a clean cloth before taki...

1.0 OBJECTIVE To provide standard operating procedure for giving stores numbers to the material. 2.0 SCOPE Store Department. 3.0 RESPONSIBILITY Store Incharge. 4.0 ACCOUNTABILITY Store Incharge. 5.0 PROCEDURE 5.1 Receive the material according to SOP-ST-001 5.2 Transfer the material to quarantine area. 5.3 Store number is given according to following coding- a) For e.g. EM/001/99 (Store's number for Raw/Packing Material) for Emcure b) EPA/001/99 (Stores number for Production Aid) c) Where EM/ are Code No. for Emcure material. d) /001/ mentions the serial number of material. e) /99 mentions year of material received. 5.4 After giving the stores number enter this numbers into G.R.N. & send this G.R. to Q.C. Dept. for further procedure. 6.0 REVIEW DATE After ...

1.0 AIM To provide standard operating procedure for dispensing the raw material. 2.0 SCOPE Stores Department. 3.0 RESPONSIBILITY Stores Incharge/Workmen concerned. 4.0 ACCOUNTABILITY Stores Incharge. 5.0 PROCEDURE 5.1 Check the required Qty. against the requisition slip. 5.2 Check the cleanliness of dispensing room. 5.3 Ensure that there is no material of other batch. 5.4 Check the lot No. Potency, Mfg. Date, Expiry Date, of the material to be dispense. 5.5 Wear mask & gloves for dispensing. 5.6 Switch ON the balance. Check the cleanliness of balance. Weigh on the mechanical balance by using Std. Weights. 5.7 Transfer one material at a time in the dispensing room. 5.8 Weigh the material in front of the QC Oficer & Production Officer. 5.9 Enter the weighing recor...

1.0 AIM To provide standard operating procedure for closing the Store Department. 2.0 SCOPE Store Department. 3.0 AREA OF OPERATION Store Dept. 4.0 RESPONSIBILITY Store Incharge. 5.0 ACCOUNTABILITY Stores Incharge. 6.0 PROCEDURE 6.1 Check the cleanliness. 6.2 Lock the Raw material store by ensuring cleanliness. 6.3 Switch 'OFF' the lights of every dept. 6.4 Lock the store dept. 6.5 Put the seal on lock sign of stores incharge, time & date. 6.6 Lock the store only inpresence of Store's Incharge. 7.0 REVIEW DATE After 2 years or when procedure is changed.

1.0 AIM To provide standard operating procedure for calibration, operation and cleaning of weighing balance. 2.0 SCOPE Production Department. 3.0 AREA OF OPERATION Store Department. 4.0 RESPONSIBILITY Operator concerned 5.0 ACCOUNTABILITY Stores Incharge. 6.0 CALIBRATION 6.1 Check the clenliness of the balance & weighing area. 6.2 For calibration of the balance standard weights which are calibrated are used. 6.3 Level the balance properly. 6.4 Select the standard weights according to the capacity of balance i.e. lower weight, middle weight, & upper weight of a balance capacity. 6.5 Switch ON the balance adjust to "0". 6.6 Place standard weight one by one on the weighing pan & record the reading in the balance calibration record. 6.7 Check that the observed weights are with in the limits. Acce...

Date of Receipt______________ Delivery Challan / Invoice No.:__________________________Dated:______________ Name & Address of Supplier:__________________________________________________ ________________________________________________________________________ Name of items mentioned in Delivery challan / Invoice (D / C / Inv.) 1. _______________________________ 2. _______________________________ 3. _______________________________ 1.0 Check the following (a) Whether total number of containers mentioned in (State total No. of DC / Inv. tallies with the containers) number of containers received? Yes / No b) What is the break-up of of items and number of containers. Name of Number of items containers _________...