Pharmaceutical Updates was started to share knowledge among the pharma professionals & it will become helpful to the pharma Professionals. The author of pharmaceutical updates is Chandrasekhar panda who is having more than 13 years of Experience in Pharmaceutical Quality Assurance department and he has worked in Pharma Companies like Cipla, USV & Aurobindo Pharma Limited.
Warehouse head or designee shall receive communication from supply chain or PPIC department about the supply of raw material to the manufacturing facility.
On receipt of the vehicle, security department of the facility shall inform to warehouse supervisor about the arrival of material. Security person shall collect the documents from the transporter and handover to the warehouse department. The documents shall be material invoice, certificate of analysis, Material Safety Data Sheet (MSDS).
On receipt of the documents, warehouse person shall check the documents against purchase order, material entry into the Electronic Material Management System and vendor approval status and supplier approval status.
The documents received from the supplier should possess the purchase order number on the document to ensure receipt of correct material at the time of receipt.
Material manufacturer’s address on Certificate of Analysis (CoA), and container label must be matched with approved vendor list. While checking the address, company name, plot number, address, street name, pin code and all other minute details should be checked and ensure compliance.
In case of material manufacturer as well as supplier, details of manufacturer as well as supplier with address must have to be in line with the approved list in the received documents.
In case of material manufacturer’s address is not mentioned on CoA or container, batch number on CoA shall be verified against batch number available on container label. Batch number should be matched with each other and full address in-line with approved vendor list must have to be match with either CoA or material container label.
Once all documents found compliant, warehouse personnel shall allow the vehicle to enter in the factory premises.
At a time only one vehicle shall be attended by warehouse person. The vehicle shall be taken to the receipt bay. It should be placed in such a way that vehicle should not be open in open roof.
Vehicle should be verified for its cleanliness, smell and it is received with what other kind of materials. Vehicle should available in clean condition; it should not have any abnormal smell and condition, it should not have received with any poisonous chemical, poisons, insecticides, food material etc. vehicle inside condition should be dry.
Material shall be unloaded on the receipt bay. In case of multiple batches received, it shall be unloaded batch wise on clean pallets.
After unloading the material, warehouse personnel shall de-dust the materials outer surface of each container with vacuum cleaner or clean dry duster.
Material pallet should be verified at the time of receipt. It has to ensure that the wooden pallet should not have preservative treatment of halogenated-phenolic compound and Pallet certificate must have to be acquired at the time of receipt ensuring above requirement.
The received material shall be transfer on the company’s Stainless Steel (SS) pallets. Material pallet shall be taken into the material movement air lock. Before taking the material into the airlock and while opening the door of airlock, air curtain shall on to break air movement from outer side to inside and to prevent the contamination.
Material shall be ensured as per material receipt checklist. The checklist shall contain following information:
Certificate of analysis from the manufacturer, Approved Vendor and supplier
Storage condition of material
Cleanliness of vehicle
Smell of vehicle for any abnormality
Spillage of material in the vehicle
Possibility of Material contamination because of any other means.
Material should not accompany food, harmful chemical such as pesticides, controlled substance etc.
Integrity of the seal
Seal number of container should be matched with serial numbers provided by manufacturer when they have dispatched the material from their facility
The integrity of the containers
Container physical condition – material container should not have any damage
Material labeled for complete address of manufacturer
Data logger must have received with cold chain materials
Pallet certificate to ensure that the pallets are not treated with halogenated-phenolic compound
Pre-sterilized material must have to be verified for sterilization evidence as applicable i.e. Gamma eradiation evidence, ETO (Ethylene oxide) etc.
Weigh the material for gross weight. The weight of gross weight should not be differing from 2.5 % of the weight specified on the container.
Once the material is taken into the air lock, air clock shall be closed. Material shall be de-dusted using vacuum cleaner or lint free duster.
When receipt of material any discrepancy with respect to above point is noted, record the same in the checklist. Inform to the warehouse head and Quality Assurance (QA) person.
In case of condition of material is not acceptable, QA person shall reject the material by affixing the rejected label on the specific container or entire consignment depending on the situation.
The identified defect can be classified as follows:
Critical Defects: Damaged container and material is spilled, material exposed to the environment, missing seal, less than acceptable tolerance.
Major Defects: Outer container is damaged or deformed but inner bag found intact.
Minor Defects: Containers with dent surface but integrity is maintained.
Record the rejection in material discrepancy note and it shall be signed by warehouse and QA person. Depending on the types of defect, material can be returned to vendor after completion of documentation.
In case of material is rejected and cannot be sent to manufacturer back immediately, it shall be stored at appropriate storage condition as per label claim.
When receipt of material, if any label found torn but information is intact, the label can be laminated with lamination film to keep the material label information intact.
On satisfactory verification of material, material inward entry shall be done in the material management software.
In case of material outer container found damaged but inner container is intact, inner bag shall be transfer to new similar container (material of construction and specification of the container should be same. Label from original container should also be affixed to new container.
Once the material inward done in the material management software, it shall be labeled with quarantine labels and placed at designated location.
While entering the information in the material management software, care should be taken to ensure that correct information is entered and second person shall verify the information for its accuracy.
Batch number and expiry date are critical information for the traceability and validity of the material.
Expiry date shall be entered in the system as follows:
Allocate the expiry date based on date specified on CoA and container label.
If the expiry date is not specified and other terminology is used by material manufacturer such as valid up to, best before, use before, this information shall be considered as expiry period of the material.
In case if the container does not have expiry period but re-test period only, the retest period shall be considered as expiry. In such cases, the expiry date can be extended when manufacture provide supporting stability data to support shelf life extension. Such cases should be handled through appropriate QMS tool.
In case of cold chain material, it is required to ensure that material received along with data logger. The data shall be downloaded and reviewed for any excursion. If temperature excursion is noted, the event shall be investigated and recorded. Impact of excursion shall be evaluated before it is release for use.
While receipt and transfer of material which is sensitive to static electricity/ static charge, adequate measure such as earthling of container should be done before material handling.
In case of any exposure of material to human, instruction provided in the MSDS should be followed .