{"id":4955,"date":"2026-10-08T15:54:47","date_gmt":"2026-10-08T07:54:47","guid":{"rendered":"https:\/\/pharma-reliance.com\/?p=4955"},"modified":"2026-10-08T15:54:47","modified_gmt":"2026-10-08T07:54:47","slug":"standard-operating-procedure-sop-for-active-pharmaceutical-ingredient-api-manufacturing-proces-%e3%80%90-part-2-%e3%80%91","status":"publish","type":"post","link":"https:\/\/pharma-reliance.com\/zh\/standard-operating-procedure-sop-for-active-pharmaceutical-ingredient-api-manufacturing-proces-%e3%80%90-part-2-%e3%80%91\/","title":{"rendered":"Standard Operating Procedure (SOP) for Active Pharmaceutical Ingredient (API) Manufacturing Proces \u3010 Part -2 \u3011"},"content":{"rendered":"

5.2 Process Flow Diagram (English)<\/strong><\/h4>\n

Starting Materials (QC Verified) \u2192 Charging\/Feed Preparation \u2192 Chemical Synthesis (Controlled Temp\/Pressure\/Time) \u2192 Quenching (Quenching Agent Added) \u2192 Phase Separation (Organic Phase Retained) \u2192 Crude Product Isolation (Filtration\/Centrifugation) \u2192 Purification (Distillation\/Extraction\/Recrystallization, QC Purity Test) \u2192 Drying (Vacuum\/Fluid Bed, Moisture Test) \u2192 Milling & Sizing (Particle Size Test) \u2192 Final QC Testing (Comprehensive Inspection) \u2192 Qualified API \u2192 Bulk Packaging & Storage<\/p>\n

 <\/p>\n

6. Safety Requirements<\/strong><\/h4>\n

Operators must wear personal protective equipment (PPE) during operation, including gloves, goggles, protective clothing, and gas masks (if using toxic or corrosive materials).<\/p>\n

Strictly abide by the safety operation regulations of chemical reactions, especially for exothermic reactions, to prevent overheating, pressure buildup and other dangerous situations.<\/p>\n

All solvents, catalysts and other chemicals must be stored in dedicated containers, labeled clearly, and stored separately according to their properties (such as flammable, corrosive, toxic).<\/p>\n

The operation site must be equipped with fire-fighting equipment, emergency washing facilities and first-aid supplies, and operators must be familiar with their use methods.<\/p>\n

In case of abnormal situations (such as leakage, fire, explosion), immediately stop the operation, evacuate personnel, and report to the supervisor and safety department in a timely manner.<\/p>\n

 <\/p>\n

7. Record Requirements<\/strong><\/h4>\n

All operation steps, process parameters, sampling results, QC test results and abnormal situations must be recorded accurately, completely and timely in the API Manufacturing Record Form.<\/p>\n

Records must be filled in with black or blue ink, and any modification must be signed by the modifier and indicate the modification date; no erasure or alteration is allowed.<\/p>\n

Manufacturing records must be reviewed by the manufacturing supervisor, and archived for at least 5 years after the expiration date of the API batch.<\/p>\n

 <\/p>\n

8. Annex<\/strong><\/h4>\n
Annex 1: Supplementary Process for Sterile API<\/strong><\/h5>\n

After Step 5 (Purification), the purified API is transferred to a clean area (class A\/B) for sterile processing.<\/p>\n

Dissolution: Dissolve the purified API in a sterile solvent (meets injection grade standard) under sterile conditions, stir until completely dissolved.<\/p>\n

Sterile Filtration: Filter the dissolved solution through a sterile filter (pore size: 0.22\u03bcm) to remove microorganisms and particles.<\/p>\n

Aseptic Crystallization: Transfer the sterile filtrate to an aseptic crystallization vessel, cool slowly to induce crystallization under aseptic conditions.<\/p>\n

Freeze-Drying\/Spray-Drying: Dry the aseptic crystal mixture by freeze-drying (temperature: -40 to -50\u2103, pressure: \u22640.01MPa) or spray-drying (inlet temperature: 120-140\u2103, outlet temperature: 60-80\u2103) under sterile conditions.<\/p>\n

Sterile API Packaging: Package the dried sterile API in sterile, sealed packaging containers under class A clean conditions, label clearly, and store in a sterile storage room.<\/p>\n

 <\/p>\n

9. Revision History<\/strong><\/h4>\n\n\n\n\n
Revision No.<\/td>\nRevision Date<\/td>\nRevision Content<\/td>\nApprover<\/td>\n<\/tr>\n
01<\/td>\nYYYY-MM-DD<\/td>\nInitial Release<\/td>\nXXX<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Approved by: ________________________ Date: ________________________<\/p>\n

Distributed to: Manufacturing Department, QC Department, Technical Department<\/p>\n

 <\/p>","protected":false},"excerpt":{"rendered":"

5.2 Process Flow Diagram (English) Starting Materials (QC Verified) \u2192 Charging\/Feed Preparation \u2192 Chemical Synthesis (Controlled Temp\/Pressure\/Time) \u2192 Quenching (Quenching […]<\/p>\n","protected":false},"author":1,"featured_media":4887,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_angie_page":false,"postBodyCss":"","postBodyMargin":[],"postBodyPadding":[],"postBodyBackground":{"backgroundType":"classic","gradient":""},"page_builder":"","footnotes":""},"categories":[58],"tags":[],"class_list":["post-4955","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-gmp-fda-validation"],"_links":{"self":[{"href":"https:\/\/pharma-reliance.com\/zh\/wp-json\/wp\/v2\/posts\/4955","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharma-reliance.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharma-reliance.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharma-reliance.com\/zh\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharma-reliance.com\/zh\/wp-json\/wp\/v2\/comments?post=4955"}],"version-history":[{"count":2,"href":"https:\/\/pharma-reliance.com\/zh\/wp-json\/wp\/v2\/posts\/4955\/revisions"}],"predecessor-version":[{"id":4957,"href":"https:\/\/pharma-reliance.com\/zh\/wp-json\/wp\/v2\/posts\/4955\/revisions\/4957"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharma-reliance.com\/zh\/wp-json\/wp\/v2\/media\/4887"}],"wp:attachment":[{"href":"https:\/\/pharma-reliance.com\/zh\/wp-json\/wp\/v2\/media?parent=4955"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharma-reliance.com\/zh\/wp-json\/wp\/v2\/categories?post=4955"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharma-reliance.com\/zh\/wp-json\/wp\/v2\/tags?post=4955"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}