The Ultimate Resource for Pharmaceutical SOPs and Best Practices
Protocol for Handling Returned and Expired Drugs in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedures for the proper handling, documentation, and disposal of returned, expired, or unused investigational drugs used in Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry. Scope This SOP applies to…
Protocol for Managing Participant Withdrawals in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for handling participant dropouts and withdrawals from Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry. Scope This SOP applies to all study personnel involved in participant recruitment, enrollment, and study conduct,…
Protocol for Implementing CAPA in BA/BE Study Facilities Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for identifying, implementing, and verifying corrective and preventative actions (CAPA) to address non-conformities, deficiencies, and potential risks identified during Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry. Scope This SOP applies…
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Protocol for Addressing Audit Observations in BA/BE Study Facilities Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for responding to audit findings and implementing corrective actions to address deficiencies identified during audits of Bioavailability (BA) and Bioequivalence (BE) study facilities in the pharmaceutical industry. Scope This SOP applies to all…
Protocol for Conducting Audits in BA/BE Study Facilities Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for conducting audits of clinical and bioanalytical facilities involved in Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry. Scope This SOP applies to all personnel involved in auditing activities, including Auditors,…
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Protocol for Managing Conflict of Interest in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the identification, disclosure, and management of conflicts of interest among personnel involved in Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry. Scope This SOP applies to all study personnel, including…
Protocol for Study Personnel Training in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the training of personnel involved in the conduct and oversight of Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry. Scope This SOP applies to all study personnel, including Investigators, Study Coordinators,…
Protocol for Compiling Regulatory Submissions for BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the preparation, compilation, and submission of regulatory documents for Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry. Scope This SOP applies to all personnel involved in the regulatory submission process,…
Protocol for Generating Final Study Reports in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures and responsibilities for preparing comprehensive final reports for Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry. Scope This SOP applies to all personnel involved in the generation, review, and approval…
Protocol for Document Archiving in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the systematic archiving and retention of study documents generated during Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry. Scope This SOP applies to all personnel involved in the conduct and oversight of…