PH50 VENDOR QUALIFICATIONS SOP Template
Pharmaceutical Standard Operating Procedure Template- Describes the process for selection, approval, development and monitoring of vendors providing components, materials and services used to support company products. Package consists of the procedure, a Vendor Approval Report and an Approved Vendor Lost Log.
Emailed in PDF format
PH51 NONCONFORMING MATERIALS SOP Template
Pharmaceutical Standard Operating Procedure Template- Describes the process for the identification, documentation, evaluation, investigation, segregation and disposition of nonconforming materials at the company. This procedure also provides a system to document planned or unplanned non-conformances from an effective procedure and policy. Package consists of the procedure, a Non-conformance Report (2 parts), and a Nonconforming Materials Index Log.
Emailed in PDF format
PH52 PRODUCT DISTRIBUTION, WAREHOUSING, STOCK ROTATION AND TRACEABILITY SOP Template
Pharmaceutical Standard Operating Procedure Template- Describes the process used to assure that only those drug products approved for release are distributed and to assure adequate records are maintained for distribution activities. This procedure also describes the warehousing procedures for storage of drug product and method for stock rotation and traceability of drug product. Package consists of the procedure, a Product Distribution Record, a Product Distribution History Index Log and a Storage Area Log.
Emailed in PDF format
PH53 RESERVE SAMPLES SOP Template
Pharmaceutical Standard Operating Procedure Template- Establishes a standard procedure for the labeling, storage, inspection and maintenance of reserve samples. Package consists of the procedure, a Reserve Sample Submission Record and a Reserves Samples Log. .
Emailed in PDF format
PH54 RETURNED GOODS SOP Template
Pharmaceutical Standard Operating Procedure Template- Establishes a process for the evaluation, receipt and handling of returned goods at the company. Package consists of the procedure, a Product Return Record, a Product Destruction Record, a Product Return Log and a Product Destruction Log.
Emailed in PDF format
PH55 LABELING CONTROLS SOP Template
Pharmaceutical Standard Operating Procedure Template- Describes the procedure for the control, accountability, and use of labeling associated with company products. Package consists of the procedure, a Labeling Accountability Record and a Labeling Accountability Log.
Emailed in PDF format
PH57 QUALITY AGREEMENTS SOP Template
Pharmaceutical Standard Operating Procedure Template- Describes the company procedure for creating quality agreements with contract manufacturing organizations. This includes standards for content and the process used to develop and approve a Quality Agreement with a vendor of GMP materials. Package consists of the procedure.
Emailed in PDF format