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 _________...

1.0 VACUUM DISTILLATION 1.1 Distillation under reduced pressure should always be carried out behind adequate to shields. This applies to both oil pump and water pump systems. Always use a suitable trap between the pump and the apparatus. 1.2 Evacuate the apparatus and check for leaks before commencing heating. Avoid heating by direct flame. 1.3 At the end of the distillation allow it to cool before slowly admitting air or nitrogen. Nitrogen is preferable to air on all capillary bleeds since many organic substances tend to oxidise at elevated temperatures. 1.4 Use a proprietory all glass capillary fitting. Never use rubber stoppers in distillation equipment. They tend to soften with heat and may be pulled into the distillation flask. 1.5 Do not use flat-bottomed flasks in vacuum distillation. 1.6 Do not use water cooled condensers if the temperature of the distillate entering the condenser ...

1.0 OBJECTIVE 2.0 SCOPE 3.0 RESPONSIBILITY Q.C. Officer , Q.C. Incharge. 4.0 PROCEDURE Safety Audit of individual department is carried out once in three months .The audit team comprises of Safety , Officer , Concerned department head and maintenance manager . Basically the audit is to find out unsafe acts and unsafe conditions in department and to comply the same. Apart from schedule safety audit, safety officer takes daily round covering all departments and the critical findings are highlighted to the concerned department and for rectification through internal memo.

1.0 OBJECTIVE 2.0 SCOPE 3.0 RESPONSIBILITY Q.C. Officer , Q.C. In-charge . 4.0 PROCEDURE 1. The stock of safety items is maintained by the safety officer . The minimum level of each item is derived and same is maintained. 2. In case of personel protective items the same are issued against requisition which is authorised by the concerned department. These issues are purely against replacement. The record of the same is on the individual issue card. These items are used as per their intended use which is supervised by the concerned department supervisor. 3. In case of self breathing appratus their need is identified and accordingly placed in CIMG department .This is used as per its intended the which is supervised by the concern department supervisor. 4. In case of maintenance o fpersonal protective equipments the same is taken care by t...

1.0 OBJECTIVE To lay down the procedure for Medical check up of employees. 2.0 PROCEDURE a) Receive the list of all employees dealing with the manufacturing and testing ( Formulation production and QCL ) ( It is sent by Fire & Safety dept ) b) Inform to respective section and chief Medical Officer the schedule of medical check up. c) As per schedules, send employees for medical check up. d) Arrange medical check up of all employees e) Arrange medical check up of all employees yearlyly to ensure that employees are free from contagious discuss and infections. f) Study the comments obtained from chief Medical Officer ( CMO ) and inform the concerned department with a request not to allow and the employee for working if ...

1.0 OBJECTIVE 2.0 SCOPE 3.0 RESPONSIBILITY Q.C. Officer , Q.C. In-charge . 4.0 PROCEDURE 1. Carry all the extinguisher to the place of fire and keep it upright. 2. Remove the safety clip and strike the knob located in the cap to actuate the piercing mechanism which in turn break the sealing disc of the cartridge. 3. Direct the stream of escaping powder at the base of the flame. 4. For effective result stand about 5 to 8 feet away and direct the stream near the seat of the fire . 5. Progress forward, moving the nozzle rapidly with a side to side sweeping motion. 6. When using on outdoor fires always operate the extinguisher from the upwind side of the fire to extend the effective range of the spray.

1.0 AIM To lay down a standard operating procedure for attending hazardous job. 2.0 SCOPE Maintenance Department 3.0 AREA OF OPERATION Maintenance department. 4.0 RESPONSIBILITY Operator/Maintenance Supervisor concerned. 5.0 ACCOUNTABILITY Maintenance Incharge. 6.0 NORMAL OPERATION 6.1 Any welding work to be carried out is done through issuing a Hot work permit. 6.2 Concerned Engineering Supervising the job prepares and gets approved by the user department and hands over to welder. 6.3 After completion, welder engineer and user department hands over to welder. 7.0 For any confined space working, user department issues a note for carrying out. 7.1 Electrical fuses are removed and they are kept with the person entering a confined vessel. ...