cl-ibp-02

الصحة وزارةالصيدلية للشئون المركزية اإلدارة

للتفتيش العامة اإلدارةالمستحضرات التفتيشعلى ادارة

الحيوية

Ministry of HealthCentral Administration for

Pharmaceutical AffairsGeneral Inspection DepartmentBiological Product Inspection

Department Code No. CL-IBP-02

Tel.: +202 – 23684288 +202 – 25354100 +202 – 23640368 Ext.:1502 Fax: +202 - 23684194Website: www.eda.mohp.gov.eg Version: 01 Email: [email protected]

Finished Goods Warehouse Audit ChecklistLocation: Date:Auditor:

Item no. Item Answers Comments on items

1 Storage and Distribution1.1

Is there a system to prevent the unintentional or unauthorized person’s access from entering the storage area?

Yes No

1.2 Is there a management system for the location indicating responsibility and authorization?

Yes No

1.3 Is there a signature log for authorized persons for receipt or dispatch activities?

Yes No

1.4 Are there a quality unit controlling the activity in this (contracted) warehouse?

Yes No

1.5 Is there a license for location? Yes No 1.6 Is a cold room available? Yes No

1.7 Are storage conditions consistent with GSP guidelines? Yes No

1.8 Are the temperature and humidity monitored?. Yes No

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1.9 Are temperature and humidity controlled? Yes No

1.10 Are monitoring records kept in a proper system? Yes No

1.11 Are the storage areas designed and adapted to ensure good storage conditions?

Yes No

1.12 Are there sufficient & effective provisions for fire-fighting equipment in place?

Yes No

Item no. Item Answers Comments on items2 Sanitization and Pest control

2.1 Is there sanitation program available indicating frequency of cleaning and methods to be used to clean the storage areas?

Yes No

2.2 Pest control program exist and pest control agents are safe? Yes No

2.3 Is there appropriate procedure for clean up of any spillage to ensure complete removal of any risk of contamination?

Yes No

3 Capacity and handling of goods3.1 Is there sufficient capacity to allow the orderly storage of various

categories of products?Yes No

3.2 Are there product stirred off floor and suitably spaced to permit safe handling and inspection?

Yes No

3.3 Are the receiving and dispatch bays protecting materials and products from weather?

Yes No

3.4 Are there any physical or electronic segregation (be) provided for the storage of expired and or recalled products?

Yes No

3.5 Are the products and area concerned appropriately identified? Yes No

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3.6 Are the finished products (is) handled and distributed in such a manner to prevent cross contamination?

Yes No

Item no. Item Answers Comments on items Item no.

3.7 Are the first expiry /first out (FEFO) principle being followed? Yes No

3.8 Are storage conditions for pharmaceutical products in compliance with the labeling?

Yes No

3.9 Are temperature and humidity mapping showing uniformity of temperature across the storage facility?

Yes No

3.10 Are temperature monitors located in storage areas? Yes No

3.11 Are there adequate lighting to enable safe and accurate operations Yes No

4 Documentation4.1 Are there records for each consignment describing batch no /qty per

batch/mfg date /expiry dateYes No

4.2 Are records retained for one year after the expiry date of products to be observed?

Yes No

4.3 Are there comprehensive records showing receipt and dispatches of finished products to a specified system? /expiry date

Yes No

4.4 Are there a tracking records or report batch wise for each product? Yes No

4.5 Is there a verification system to check the receipt goods against the relevant documents (receipt note)?

Yes No

Item no. Item Answers Comments Item no.

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on items4.6 Is there a verification system to check the delivered goods against

relevant invoices?Yes No

4.7 Are records for dispatch will stating at least 1-the dispatch date2-customers name and address 3-products dispatched with all products details /batch number/quantities ( after the expiry date of products to be observed)?

Yes No

4.8 Is periodic stock reconciliation (be) performed by comparing the actual and recorded stokes/Monthly basis? (daily at random)

Yes No

4.9 Are all records readily accessible and available on request? Yes No

5 Is there a system to Control (of) obsolete and expired finished products Yes No

5.1 Are stocks checked regularly for expired goods ? Yes No

5.2 Are all due precautions be observed to prevent the dispatch of expired batch?

Yes No

6 Validation Documentation

6.1 Are written validation protocols used that specifies how validation of temperature and humidity mapping will be done? What are the critical process steps and acceptance criteria? Does the quality unit approve the protocols?

Yes No

6.2 Do validation reports include results obtained? Do these reports discuss any deviations observed and recommend changes to correct deficiencies

Yes No

7 Qualification

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7.1 Are periodic reviews of systems and processes conducted to verify that they are still operating in a validated state?

Yes No

7.2 Have thermometers and hygrometers been calibrated and qualified for use?

Yes No

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cl-ibp-02

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