Quality Assurance Starts with Raw Materials

At PCI Synthesis, we are committed to producing Quality products. We have many systems that work together to ensure that all of our products meet and/or exceed their specifications.

Posted: January 15, 2010

API Manufacturing and Pharmaceutical Manufacturing

At PCI Synthesis, we are committed to producing Quality products. We have many systems that work together to ensure that all of our products meet and/or exceed their specifications. Quality assurance is a crucial part of producing products that meet their specifications. This is accomplished by having the correct documents in place so that all parts of a process run smoothly and correctly, by checking finished documents for errors or deviations, and by ensuring that all needed testing is completed and documented.

The single largest function of Quality Assurance at PCI is to ensure that the documents that are needed are accurate and available. This includes batch records, quality specification sheets, analytical methods, and standard operating procedures (SOP’s). Among these documents, SOP’s are a crucial part of producing quality products. SOP’s ensure that operations are consistently conducted in a manner that protects the operator and the product. SOP’s ensure that activities are conducted the same way each and every time they are preformed. One such SOP that is key to ensuring the quality of all products is in the areas of receiving, storage, identification and in the traceability of raw materials. The following is an overview of that SOP that we use at PCI Synthesis.
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Prior to a raw material arriving on site, the materials management personnel receives a completed copy of the Bill of Materials from production after the purchase order for the raw material(s) has been issued. This document will inform receiving personnel of the material ordered, the quantity, the vendor, the purchase order number, and the expected delivery date. The materials management personnel keep the Bill of Materials in an active file until all the material has been received and warehoused. Once a raw material is delivered to PCI, the materials management personnel will check to make sure the material has a completed and signed Certificate of Analysis (C of A) from the vendor. If the C of A is not received in advance or did not accompany the shipment, the personnel will notify the purchasing department immediately so the vendor can be contacted and the appropriate C of A will be faxed to us. Release to manufacturing by QC cannot occur without an appropriate C of A.

Next, the materials management personnel determine that the identification and quantity or amount received matches the amount ordered, as specified on the Purchase order. The materials management personnel inspects the material to make sure that all containers or packaging are clearly and accurately labeled and that the lot number on each package matches the Lot Number on the accompanying Certificate of Analysis. They also check that the condition of the containers or packaging is satisfactory, making sure that there are no punctures, leaks, and/or excessive rust, and that all containers are adequately sealed. All raw materials must be accompanied by an MSDS unless PCI already has a copy on file.

If any of the following applies to the material, it shall constitute sufficient reason to immediately refuse receipt of a raw material.
  • If the raw material packaging is damaged so as to compromise material integrity
  • Raw material received is different in identity from what was ordered
  • Raw material identity is uncertain
  • Materials cannot be safely unloaded

In these cases, PCI personnel shall not unload the raw material but shall instruct the shipper to return it to the sender, and immediately notify Purchasing of the situation. If the received raw material is rejected for any reason and cannot be immediately returned to the vendor, that material is considered Out of Specification (OOS). The Material will be labeled with a raw material Out of Specification – Reject label. All packages of OOS material will be moved to the quarantine OOS area of the appropriate storage facility. The materials management personnel will then complete a raw material out of specification form and forward it to QC and Purchasing Departments immediately. Purchasing will then contact the vendor to arrange for return and / or credit for the OOS material and arrange for reordering if necessary.

All Raw Materials that are received in satisfactory condition are handled by the materials management personnel as follows:
  • A yellow “Hold for QC Approval” label is applied to the each package or container of Raw Material, indicated on the label is the total number of containers of each material received and the materials stock number.
  • The material is then moved to the appropriate warehouse area. The materials management personnel fill out a Raw Material Checklist and attach it to the C of A and forward both to Quality Control to indicate that the raw material has been received and warehoused.
  • The Receiving/Warehouse personnel log the received raw materials into the Company’s inventory database management system. The information contained in this database includes: the material name, the vendor name and lot number, the quantity of material, the date received, and the final material disposition and date of approval or rejection.
  • The materials management Personnel attaches the remaining paperwork that accompanies a shipment to PCI’s Bill of Material form and forwards the paperwork to the Accounts Payable department.
  • Upon receipt of a raw material, QC accesses the raw material specification sheet to determine its sampling needs. Once QC has analyzed the raw material, the final disposition of the raw material is assigned by the Quality Control Manager.
  • QC generates labels for each container of raw material in accordance with its disposition. If the material is approved and released a green Raw Material Approved and Released by QC label is assigned for every container of each lot of raw material that complies with PCI specifications.
  • If the material is rejected a pink Raw Material Out of Specification – Reject label is created and assigned for every container of each lot of raw material that fails to comply with PCI specifications.
  • Either QC or Materials personnel apply the appropriate disposition label to the containers. The disposition label is adhered to the surface of the Raw Material Hold label, slightly offset to reveal the presence of the Hold label beneath. The disposition label must be completely filled out, with material name, vendor, lot number, container number, total container numbers, initials and date.
  • Raw Materials that QC determines to be OOS should be properly disposed of or returned to suppliers in a reasonable time frame.

Materials are transferred from the warehouse to the manufacturing plant on an as-needed basis only. Upon completion of manufacturing, the warehouse personnel transfers any unused raw materials back to the warehouse. All partial containers are reweighed and restocked. The material consumption is then entered into the inventory management database by production personnel upon completion of the manufactured batch.

Once all of these steps have been completed, PCI will have either a product ready for testing or an out of specification raw material that will either be sent back to the supplier or destroyed. This is the progression that all materials follow when they are ordered and received here at PCI. Because this SOP is followed every time, we do not have raw materials being used that are out of specification. PCI ensures that any material that is received is inspected, tested, and tracked correctly. This ensures that when a material is used it produces the high quality product for which it was intended.

About the Author

Ed Price CEO of PCI Synthesis
Ed is the President and CEO of PCI Synthesis (PCI), he serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst. Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA).

Do you have questions? Talk to Ed.