The Ultimate Resource for Pharmaceutical SOPs and Best Practices
The purpose of this Standard Operating Procedure (SOP) is to define a systematic process for managing stability study data. This ensures accuracy, integrity, and regulatory compliance for all stability study records maintained throughout a product’s lifecycle.
Click to read the full article.
The purpose of this Standard Operating Procedure (SOP) is to establish a standardized approach for ensuring compliance with stability study guidelines, including ICH Q1A(R2), WHO GMP, and local regulatory requirements. This ensures the reliability of stability data and regulatory adherence.
Click to read the full article.
The purpose of this Standard Operating Procedure (SOP) is to establish a systematic process for reviewing trends in stability studies of ointments. This ensures timely identification of potential stability concerns, compliance with regulatory requirements, and continuous product quality improvement.
Click to read the full article.
The purpose of this Standard Operating Procedure (SOP) is to define the process for documenting stability study results for ointments. This ensures that stability data is recorded systematically, analyzed accurately, and maintained for regulatory compliance.
Click to read the full article.
The purpose of this Standard Operating Procedure (SOP) is to define the process for preparing stability study protocols for ointments. This ensures that stability studies are conducted systematically, following regulatory guidelines and Good Manufacturing Practices (GMP).
Click to read the full article.
The purpose of this Standard Operating Procedure (SOP) is to define the process for real-time stability monitoring of ointments to assess their physical, chemical, and microbiological stability under actual storage conditions over the product’s shelf life.
Click to read the full article.
The purpose of this Standard Operating Procedure (SOP) is to define the process for conducting photostability testing of ointments to assess their physical, chemical, and microbiological stability when exposed to light. This ensures that the formulation remains stable under normal and intense light exposure conditions.
Click to read the full article.
The purpose of this Standard Operating Procedure (SOP) is to define the procedure for conducting stability testing of ointments under varied humidity conditions to assess their physical, chemical, and microbiological stability when exposed to different environmental humidity levels.
Click to read the full article.
The purpose of this Standard Operating Procedure (SOP) is to define the procedure for conducting long-term stability testing of ointments to assess their physical, chemical, and microbiological stability over an extended period under recommended storage conditions.
Click to read the full article.
The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for conducting accelerated stability testing of ointments to evaluate the product’s physical, chemical, and microbiological stability under stressed environmental conditions.
Click to read the full article.