The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Preparation of Lyophilized Biologics Standard Operating Procedure for Preparation of Lyophilized Biologics 1) Purpose This SOP outlines the process for preparing lyophilized biologics, ensuring product stability, bioactivity, and proper storage conditions. 2) Scope This SOP applies to all personnel involved in the formulation, preparation, and testing of biologics that undergo lyophilization for long-term…
SOP for Manufacturing Nasal Sprays for Pediatric Use Standard Operating Procedure for Manufacturing Nasal Sprays for Pediatric Use 1) Purpose The purpose of this SOP is to outline the procedures for formulating and manufacturing nasal sprays specifically designed for pediatric use. Pediatric nasal sprays must meet stricter safety, dosage, and formulation requirements due to the…
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SOP for Formulation of Cationic Liposomes for DNA Delivery Formulation of Cationic Liposomes for DNA Delivery 1) Purpose The purpose of this SOP is to describe the procedure for the formulation of cationic liposomes for DNA delivery. Cationic liposomes are used for delivering genetic material such as plasmid DNA or siRNA into cells due to…
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SOP for Formulation of Protein-Based Nanoparticles Standard Operating Procedure for Formulation of Protein-Based Nanoparticles 1) Purpose This SOP outlines the procedure for the preparation of protein-based nanoparticles, which are widely used for drug delivery due to their biocompatibility, biodegradability, and ability to encapsulate both hydrophilic and hydrophobic drugs. 2) Scope This SOP applies to personnel…
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SOP for Formulating Lyophilized Cancer Therapeutics Standard Operating Procedure for Formulating Lyophilized Cancer Therapeutics 1) Purpose This SOP outlines the procedure for formulating lyophilized cancer therapeutics, ensuring the stability and efficacy of the active pharmaceutical ingredient (API) during lyophilization and storage. 2) Scope This SOP applies to all personnel involved in the formulation and preparation…
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SOP for Lyophilization of Nasal Powders Standard Operating Procedure for Lyophilization of Nasal Powders 1) Purpose The purpose of this SOP is to outline the procedures for lyophilizing nasal powder formulations. Lyophilization (freeze-drying) ensures the stability and shelf life of temperature-sensitive or moisture-sensitive ingredients by removing moisture under low temperature and pressure. 2) Scope This…
SOP for Preparation of Nanoparticles for Ocular Delivery Standard Operating Procedure for Preparation of Nanoparticles for Ocular Delivery 1) Purpose This SOP outlines the procedure for preparing nanoparticles for ocular drug delivery. These formulations are designed to deliver drugs to the eye with enhanced penetration, controlled release, and reduced systemic side effects. 2) Scope This…
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SOP for Incorporation of Immunomodulators in Lyophilized Products Standard Operating Procedure for Incorporation of Immunomodulators in Lyophilized Products 1) Purpose This SOP outlines the procedure for incorporating immunomodulators into lyophilized products to enhance immune response while ensuring product stability and bioactivity during lyophilization. 2) Scope This SOP applies to formulation scientists, production operators, and QA…
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SOP for Preparation of Immunoliposomes for Targeted Drug Delivery Preparation of Immunoliposomes for Targeted Drug Delivery 1) Purpose The purpose of this SOP is to describe the procedure for the preparation of immunoliposomes. Immunoliposomes are liposomes that are surface-modified with antibodies or antibody fragments for targeted drug delivery. These liposomes bind specifically to target cells,…
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SOP for Preparation of Lyophilized DNA and RNA Formulations Standard Operating Procedure for Preparation of Lyophilized DNA and RNA Formulations 1) Purpose This SOP outlines the procedure for preparing lyophilized DNA and RNA formulations to ensure the stability and preservation of genetic material during storage and transportation. 2) Scope This SOP applies to all personnel…
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