Dossier submission guidelines in Srilanka

https://nmra.gov.lk/images/PDF/guideline/Guideline-on-regitration-of-Medicines.pdf 

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Sop for Registration of drug for export purpose in Pakistan

	Company Name Regulatory affairs department Standard Operating Procedure
Title		PAGE NO. :
Post approval changes Registration of drug for export purpose

PREPARED BY :	DATE :	CHECKED BY :		DATE:	APPROVED BY :		DATE:
REGULATORY AFFAIRS OFFICER
CONTENT 1)    PURPOSE 2)    SCOPE 3)    REQUIRMENTS     1)    PURPOSE To provide detailed guidelines according to the Drug regulatory authority of Pakistan  2)        SCOPE To ensure that their companies comply with all of the regulations and laws pertaining to their business. To Work with federal, central, state, and local regulatory bodies and personnel on specific issues associated with their business, working with such agencies as the Food and Drug Administration, European Medicines Agency (pharmaceuticals and medical devices). To advise their company on the regulatory affairs and climate that would affect proposed activities. Describing the "regulatory climate" around issues like the promotion of prescription drugs compliance. 2 REQUIRMENTS. FOR LOCALLY MANUFACTURED PRODUCTS Registration of drug for export purpose. a. Application on Form 5 with required fee as per relevant SRO. b. NOC for CRF clearance. c. Copy of approved section from CLB. d. Copy of last inspection report. e. An undertaking that applied registration is exclusively for export purpose and Will not be sold in Pakistan. f. If formulation / product is not registered in Pakistan, then export order from Importing country.

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SOPs of Handling expired and damaged stock

Standard Operating Procedure (SOP)
Title	Handling of expired and damaged stock
QA Signature		Area Manager Signature
Date of signature		Date of signature

1.                  Purpose

The purpose of this SOP is to lay down the procedure for disposal of expired, damaged, near expiry, recalled and sales return products and stability, reference samples received from Sales Depots (Stock Points) QA departments at Ware house.

2.                  Scope

This Standard Operating Procedure is applicable to central ware house

3.                 Definitions

3.1         This Standard Operating Procedure (SOP) is an authorized written procedure, providing instructions for disposal of expired products, near expiry products and damaged products received at Warehouse.

4.                 Responsibilities

Activity	Responsibility
Receiving of the stocks and documentation, Obtaining approval for destruction, Sending the  waste  for incineration	Trained Ware House staff
Stock dispatch to	Expiry Department Manger
Ensure Compliance	Supplier Relations Manager / Logistics Manager / Director- Distribution / Director – QA & Supply chain

5.                 Procedure

5.1         Intimation Report of near expiry received from rack supervisors as per 7 month 5 month and 3 month intimation.

5.2         Receive the broken / damaged / expired / market returns/ supplier return/near expiry goods from storage locations.

5.3    Check the stocks as per verification report of Returned Stocks, for Batch and quantity authentication.

5.4         Segregate the near expiry and damage stocks properly in separate expiry/damaged rack.

5.5         Share intimation report to Expiry department

5.6         Same month expiry stock share with Expiry department.

5.8         Obtain approval for Dispatching Stocks for Incineration after Segregation of Stocks

5.9         Share whole near expiry stock or damage stock to expiry department.

SOP/Expiry/01 - Process of Identification, Recording and Intimation to Expiry department of 6 month expiry

1.      Objective and Scope:

To define the process of communicating the items with batch numbers as per supplier requirement expiry to the expiry department.

2.      Responsibility:

Operations Head, Purchase & Planning Manager, District Manager, Shop manager, Sales staff, Warehouse Manager

3.      Process: 

3.1.    During monthly self audits as per expiry provided sheet, the shop/Warehouse staff will  identify and record all items that are due as per mentioned in given sheet.

3.2.    At the completion of the monthly self audit, the complete list of items due as per provided sheet, will be entered in a sheet named “Expiry Intimation Sheet” and emailed to the Expiry Department (with CC to relevant department.).

3.3.    A hard copy of the “Expiry Intimation Sheet” will be filed in the register “Expiry” and signed by the shop/warehouse manager.

3.4.    The stock that has been highlighted will be taken out of its normal rack and moved to the expiry rack. (Stock from the expiry rack can continue to be sold) 

4.      Related Document(s):

Expiry Intimation Sheet

SOP/Expiry/02 - Process of communicating 6 month expiry to suppliers

1.      Objective and Scope:

1.1.    To define the process of communicating items that is nearing expiry to relevant suppliers as per sheet.

2.      Responsibility:

2.1.    Purchase & Planning Manager, Expiry department

3.      Process

3.1.    Expiry department is required to verify if each  location (hospital, community & Warehouse) has communicated its near expiry stock through an “Expiry intimation sheet”; all branches has to sent intimation before the 26^th  of the month

3.2.    Expiry department is required to compile the data of all locations and rearrange the combined list by suppliers.

3.3.    The detailed listing of near expiry stock is to be recorded on the a separate “Supplier Expiry Intimation Sheet” for each supplier

3.4.    The supplier intimation sheet is to be communicated to each supplier before the 15^th of the following month and a hard copy of the information is to be filed in the folder labeled “Expiry Intimations to Suppliers”

4.      Related Document(s):

4.1.    Supplier Expiry Intimation Sheet

SOP/Expiry/03 - Process of dispatching near expiry stock to Expiry Department

1.       Objective and Scope:

To define the process of documenting and physically transferring stock that is due to expire in two months to the expiry department

2.      Responsibility

Shop manager, Warehouse manager, District manager, Operation heads, shop staff, warehouse staff

3.      Process:

3.1.   During the last week of each month warehouse/shop managers are required to dispatch to expiry items that are due to expire in two months, not inclusive of the current month. (example in last week of April, items expiring in the month of June will transferred to expiry warehouse)

3.2.   Warehouse/Shop staff are required to do an audit of the e
xpiry rack and separate the relevant stock and counter verify the list with “Expiry intimation sheet” of relevant month

3.3.   Shop managers will make Transfer Report  to central warehouse

3.4.   Physical stock and Transfer report of Stock will be transferred to central warehouse

3.5.   Copy of report will be filed in expiry register

3.6.   Against intimations on demand of Expiry Department, Branch/Warehouse staff will be send stock to Expiry Department.

4.      Related Document(s)

4.1.   Stock Transfer Report

4.2.   Goods Dispatch Noted

SOP/Expiry/04 - Process of receiving near expiry stock

1.       Objective and Scope:

To define the process of receiving expiry stock; segregation of returnable and not returnable items

2.      Responsibility

Expiry department in-charge, Purchase & Planning Manager

3.      Process:

3.1.         Upon receiving physical stock and Stock Transfer Report (or Goods Dispatch Note in case of central warehouse expiry), expiry department in-charge will reconcile the physical stock and documents.

3.2.         After verification expiry department in-charge will request central warehouse to issue GDN in favor of expiry warehouse

3.3.         In case of difference between physical and STR, only confirmed stock STR will be accepted

3.4.         In case any location has not physically sent any stock, expiry department will check against the locations previous intimations for relevant month and send a reminder email with CC to Purchase & Planning Manager and Head of operations

3.5.         Expiry department in-charge will segregate the returnable and not returnable stock based on prior intimations

3.6.         The details will be recorded in the “Expiry Receiving Sheet” and emailed to the Purchase & Planning Manager

3.7.         A hard copy of the monthly receiving’s will be maintained in the Expiry folder

3.8.         Company not claim (CNC), wrong and not/late intimated, loose cutting and damage stock will not be received

4.      Related Document(s)

4.1.   Expiry Deduction report (Annexure – 1)

SOP/Expiry/05 - Process of returning near expiry/expired stock to suppliers

1.       Objective and Scope:

To define the process of returning returnable expiry items to suppliers and establishing responsibility of purchase staff.

2.      Responsibility

Expiry department in-charge, Manager Purchase, Purchasers

3.      Process:

3.1.         In the first week of every month expiry department in-charge will intimate the suppliers about the expiry items under purchase dept. confidence.

3.2.         Supplier will provide evidence of return of expiry stock in the form of credit note or will deduct against an invoice

3.3.         The expiry department will enter “Return Note” in system against the evidence provided by supplier and will file the evidence and copy of return note in folder. The evidence must also be attached to the new purchase invoice and sent to accounts department for balance payment.

3.4.         At the end of the month, Expiry department in-charge is required to issue an “Expiry Stock Movement Report” which must be counter signed by the Purchase & Planning Manager & Operation Head

3.5.         All the credit notes along with system return note must be placed with manager purchase for adjustment against new purchase payment.

4.      Related Document(s)

4.1.   Return Note

4.2.   Expiry Stock Movement Report

4.3.   Supplier Credit Notes

4.4.   Supplier deduction against invoice

SOP/Expiry/06 - Process of Disposal of non-returnable expired Stock

  

1.       Objective and Scope:

To define the process of disposal of non-returnable and expired stock and establishing accountability of purchase staff

2.      Responsibility

Expiry warehouse in-charge, Manager Purchase.

3.      Process

3.1.         At each month end, Expiry department in-charge will send a report named as “Expired Stock” to the Director, Head of Finance and Manager Purchase & Planning about the non-returnable and expired stock in hand.

3.2.         Reason of expired stock must be established in the (Process of returning near expiry/expired stock to suppliers) report.

3.3.         Before disposal audit of expired stock must be conducted

3.4.         Disposal committee will authorize the disposal. Member of the committee will be as under:

3.4.1.      Director

3.4.2.      Head of Finance

3.4.3.      Head of Operation

3.4.4.      Manager Purchase & Planning

3.5.         After approval of committee expiry department in-charge is required to enter return note in the expiry system. This will reduce the expired stock in hand.

3.6.         Approval note of disposal committee along with system return note must forwarded to the accounts department for the financial recording

3.7.         Head of finance must ensure the proper book keeping

3.8.         There are different methods of disposal like return to manufacturer, Landfills, Sewer and Incineration (burning at high temperature).

3.9.         Disposal Committee will select the disposal method, however incineration is recommended.   

4.      Related Document(s)

4.1.    Expired Stock

4.2.    System Return Note

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Guidelines for allocation of cold chain items in Fridge

ALLOCATION OF COLD CHAIN ITEMS IN FRIDGE

By WHO (Technical Supplement: Estimating the capacity of storage facilities)

Cold Chain temperature requirements: 

Constant temperature between +2 to +8°C at all levels from manufacturer to the end user.Constant temperature between +8 and 15˚C.
Controlled Room Temperature between +15˚C and +25˚C.

For Specified Products:

Polio vaccines should be stored between -15 to -25°C at cold chain stores. And for delivery they should be stored between +2 to +8°C. At 1st rack of fridge.
All other vaccines should be stored between +2 to +8°C at all levels. At 1st and 2nd rack of fridge.
Drops: should be store at door of Fridge. 
Iron Supplements: should be store at door of fridge.
Softgel Capsules should be store at 8°C to 15°C or some 15°C to 25°.
Hormones: Temperature 15-25°C should be on Door of the fridge.
Suppositories: Temperature(15-25°C should be on lover portion of the door of fridge.
Ice packs/Ice plates must be on freezer/Refrigerating portion of the Fridge.
 Insulin must be on 1st portion/rack of the Fridge.

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SOP of Cold Chain management in Ware house

Standard Operating Procedure (SOP)
Title	Warehouse(Cold Chain)
QA Signature		Area Manager Signature
Date of signature		Date of signature

A cold chain is a temperature-controlled supply chain. An unbroken cold chain is an uninterrupted series of storage and distribution activities which maintain a given temperature range. It is use to extend and ensure the shelf life of pharmaceutical product.

Introduction: This document describes procedures to receive Cold chain pharmaceutical materials that will be stored in the warehouse.

Objective: To receive and dispatch the pharmaceutical, vaccines and biological products.

Responsibility: Receiver, storing, dispatching, record maintaining.                                                                                               

1.0  Receiving of Cold Chain products under the supervision of pharmacist:

The cold chain products will:

1.1  Inspect all incoming vehicles by pharmacist for the following:

·         Trucks should have controlled temperature

·         Floor boards are dry and clean.

·         Humidity should be controlled.

·         No bad odor.

1.2  Unload the shipment and inspect the condition of the shipment to ensure:

·         No damaged cases or packages.

·         On receipt of wet and damaged goods.

·         No receiving of cold products without ice plates.

1.3  Check the drivers slip to ensure the company states.

1.4  Count the goods and compare the

·         Quantity, name, expiry and lot numbers to the information stated on the shipping documents and company invoice order (IO).

·         No receiving of cold chain items if they are not in proper medical cold chain box.

·         Items must be in dry and good packaging condition.

·         No receiving in case of leakage or physically unstable packaging.

·         Investigate any discrepancies.

·         Immediately transfer the stock to Cold chain area.

1.5  Complete the “Receiving Log” under pharmacist supervision with the following information:

Product Information:

·   Received date

·   IO number

·   Expiry date

·   Lot number

·   Invoice No.

·   Quantity received

·   Shipment Supplier

·   Shipment Carrier

Vehicle Inspection:

·   Visual inspection

·   Temperature monitoring

·   Clean and dry vehicle space

·   Odor inspection

·   Pest / Rodent activity

·   Vehicle number

Note:

1.6     Once Pharmacist has approved receiving Note store product in the specific cold chain area.

2.0  Receiving of products at Cold chain /Card area:

·   Cold chain items received by only cold chain supervisor.

·   Count and recheck by invoice.

·   Save the invoice copy of cold and card items.

·   Immediately store in fridge according to their temperature requirements.

Pharmacist must check temperature, quality, registration and proper receiving of items under his supervision and sign on Purchase order for approval.

3.0  Racking and maintenance of Cold Chain items:

3.1 Pharmacist has to control the temperature and humidity of fridge and controlled area.

·         Store enough frozen icepacks for transportation.

·         Place refrigerators and freezers with space 6 inches away from wall to increase air circulation.

·         Relative humidity need to be actively controlled.

3.2. Common terms for storage

The following terms relate to temperature and medical supplies. It is important to follow the manufacturer’s recommended storage conditions for all products.

·         Store frozen: Some products, such as certain vaccines, need to be transported within a cold chain and stored at -20°C (4°F). Frozen storage is normally for longer-term storage at higher-level facilities.

·         Store at 2°-8°C (36°-46°F): Some products are very heat sensitive but must not be frozen. These are usually kept in the first and second part of the refrigerator (never the freezer). This temperature is appropriate for storing vaccines for a short period of time.

·         Keep cool: Store between 8°-15°C (45°-59°F).

·         Store at room temperature: Store at 15°-25°C (59°-77°F).

·         Store at ambient temperature: Store at the surrounding temperature. It means “room temperature” or normal storage conditions, which means storage in a dry, clean, well ventilated area at room temperatures between 15° to 25°C (59°-77°F) or up to 30°C, depending on climatic conditions.

3.3 Monitoring

·         Pharmacist has to monitor and maintain temperature and humidity record on daily bases.

·          Keep direct sunlight out of the Cold chain area.

·         system able continuously to maintain air temperatures within the set point limits throughout the validated storage volume

·         control sensors calibrated and accurate to ± 0.5 °C or better

·         Keep the record maintain from Pegasus(temperature data lodger)

Racking of Fridge Items;

·   Store all vaccines, Insulin at first and second part of fridge.

·   Rack all drops in door of the fridge.

·   Rack iron supplements, suppositories in door or lower most portion of fridge.

·   Products should be 2-3 inches away from walls.

·   No product touches the fan.

·   First-to-expire first-out (FEFO) have to maintain.

4.0  Dispatch of Cold chain products:

·         Prepare demand carefully and immediately restore it in fridge.

·         Pharmacist must check the proper ice box with ice plates to dispatch the demands.

·         Pharmacist should dispatch all cold chain products under his supervision.

·         Pharmacist should check the vehicle temperature and all medicines should be on pallet.

·         Stamp the (Dispatched note) of cold chain and controlled items after verification of proper dispatch arrangements.

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