Storage Conditions of Raw Materials and Packaging Materials, Purpose:
The purpose of this procedure is to describe the instruction of storage conditions of raw materials and packaging materials.
Storage Conditions of Raw Materials and Packaging Materials, Scope:
This SOP is applicable for storage conditions of raw materials and packaging materials to Quarantine Area, Ambient Store, AC Store, Finished Goods Store, Capsule Shell Store and Central Warehouse of XX Pharmaceuticals Ltd.
Definitions/Abbreviation:
[] Ambient Store: Storage area with normal environment condition.
[] MSDS: Material Safety Data Sheet.
Responsibilities:
The roles and responsibility is as follows:
Executive, Warehouse
[] Maintain storage conditions of all raw and packaging materials as per Manufacturer’s instruction or according to specification.
[] Record the temperature and humidity of the material storage room.
[] Follow the instructions of this procedure correctly.
Executive, Quality Compliance
[] Verify the storage conditions of raw and packaging materials.
General Manager, Plant
[] Ensure that all raw and packaging materials are stored properly.
[] Ensure appropriate personnel from the section are trained on this procedure and evaluate the effectiveness of training.
[] Confirm that SOP is technically sound and reflects the required working practices.
Head of Quality Assurance
[] Approval of SOP.
[] To ensure the overall implementation of the SOP.
Procedure:
Precaution(s):
[] Precautions must be taken to prevent unauthorized entry in the storage areas.
[] All stores must be secured with lock and key.
Storage Conditions:
Maintain Storage conditions as below:
[] Quarantine Area :Below 25°C
[] Ambient Store:Below 40°C
[] AC Store:Below 25°C
Finished Goods Store:Below 30°C
Capsule Shell Store:Temperature Below 25°C & Relative Humidity Below 60%
Central Warehouse:Below 25°C
Storage of the materials:
[] Carry out the emergency plan if temperature goes above 25°C for AC store.
[] Record the temperature and humidity for the time when temperature goes above 25°C.
[] Inform QA department immediately providing all recorded data and existing product status.
[] Check the recorded data and evaluate the sensitive material, which might temperature sensitive.
[] Send the advice to Quality Control Department for retesting of that sensitive material before use in production.
[] Carry out tests as described in the respective test method.
[] Analyze the impurity of the substance, if required.
[] Affix “REJECTED” label on the existing label of the container when retesting result does not comply with specification.
[] Prepare a list for storage condition of raw materials and packaging materials as per Annexure-VII; then take approval from Head of Quality Assurance.
[] Update the list for storage condition of raw materials and packaging materials three months to yearly or when required.
Recording of storage conditions:
[] Sr. Executive/Executive, Quality Compliance will issue the ‘Temperature & Relative Humidity Record Sheet of Warehouse’ as per Annexure-I to Annexure-VI
[] Executive, Warehouse by maintaining proper record.
[] Record the temperature and humidity of Quarantine Area, Ambient Store, AC Store, Finished Goods Store, Capsule Shell Store and Central Warehouse thrice in a day in ‘Temperature & Relative Humidity Record Sheet of Warehouse’ prepared as per Annexure-I to Annexure-VI.
[] Maintain the storage condition as per QA approved Storage Condition of Raw materials and Packaging materials.
List of Annexes
1.0 Annexure-I: Temperature Record Sheet of Quarantine Area.
2.0 Annexure-II: Temperature Record Sheet of Ambient Store.
3.0 Annexure-III: Temperature Record Sheet of AC Store.
4.0 Annexure-IV: Temperature Record Sheet of Finished Goods Store.
5.0 Annexure-V: Temperature & Relative Humidity Record Sheet of Capsule Shell Store.
6.0 Annexure-VI: Temperature Record Sheet of Warehouse Central Warehouse.
7.0 Annexure-VII: Format of Storage Condition of Raw materials and Packaging materials.