IAGIM - Drug Development Institute

IAGIM - SOPs - Pharmaceutical

Archive of SOPs- -- Pharmaceutical
Pharmaceutical - | --Analytical - | --Microbiological - | -Stability

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" High Quality Cost Effective Drug Development & Manufacturing Excellence World Wide "


The following SOP Index represents a reasonably adequate set of standard operating procedures for a drug development department to function efficiently. The development and control principles described in the standard operating procedures (about 500) are required to conduct any development study
(both NDA and Generic CTD/ANDA/AADA) to meet FDA / EC / Asian regulatory and compliance requirements and futher to manage an efficient development study using standardized product-to-product development procedures.
Specific development test method SOPs are not characterized in this list. (See analytical methods)

SOP Control  
P-000-01-2019 Template for Pharmaceutical Development SOPs.  
P-005-01-2019 Indexing procedure for Pharmaceutical Development SOPs.  
P-010-01-2019 Index for Pharmaceutical Development SOPs.  
P-015-01-2019 Signing procedures for Pharmaceutical Development SOPs.  
P-021-02-2019 Numbering and format of Pharmaceutical Development SOPs.  
P-025-01-2019 Circulation of Pharmaceutical Development SOPs.  
P-030-01-2019 Annual Review of Pharmaceutical Development SOPs.  
Development Notebooks  
P-035-01-2019 Issue and use of pharmaceutical development notebooks  
P-040-01-2019 Signing procedures for development notebooks  

P-045-01-2019 Recording pre-formulation and development formula in development

P-051-02-2019 Recording manufacturing instruction in development notebooks  
P-055-01-2019 Recording IPQC specifications in development notebooks  
P-060-01-2019 Recording finished product specifications in development notebooks.  
P-065-01-2019 Review & auditing of pharmaceutical development notebooks  
P-070-01-2019 Correction procedures in development notebooks & documentation  
P-075-01-2019 Archiving of development notebooks. Development Quality Assurance  
P-080-01-2019 Procedures For Development Change Control Development Formula  
P-085-01-2019 Operating procedures for product development.  
P-090-01-2019 Formulation of ANDA topical preparations  
P-095-01-2019 Formulation of ANDAs to Q1Q2 Status (semi-solids)  
P-100-01-2019 Validation requirements for Product Development  
P-105-01-2019 Vendor Certification requirements for Product Development  
P-110-01-2019 Check list for a pharmaceutical development report  
P-115-01-2019 SOP for Development Reports  
Active Materials  
P-120-01-2019 Active Drug Substances for Generic Drugs  
P-125-01-2019 Developing Product Formula with approved Actives  
P-130-01-2019 R&D Inventory Records for the Active Drug Substance  
Semi-Active Raw Materials  
P-131-01-2019 Choosing the Antioxidant  
P-132-01-2019 Antioxidant Qualification during Process Optimization  
Non-Active materials   
P-140-01-2019 Non-active ingredients for ANDA formula development  
P-145-01-2019 Use of Purified Water USP in Product Development  
P-148-01-2019 Qualifying NON-active ingredients for ANDA manufacture.  
P-150-01-2019 Checking excipients in the FDA 'Inactive Ingredient Guide'  
Container-Liner-Closure Systems   
P-155-01-2019 Container-Liner-Closure systems for Generic Development  
P-160-01-2019 Documentation requirements for Container/Closure systems  
P-165-01-2019 Check list for Container-Liner-Closure Documents  
In-process Controls   
P-170-01-2019 Choice of IPQC limits. P-175-01-2019 Qualification of IPQC limits.  
P-180-01-2019 Qualification of manufacturing process specification limits.  
P-185-01-2019 In process control on bulk products  
P-190-01-2019 Time limitations on manufacturing processing stages  
Finished Product Controls  
P-195-01-2019 Choice of Finished Product Specification limits  
P-200-01-2019 Qualification of Finished Product Specification limits  
Contract Laboratories  
P-205-01-2019 Auditing procedures for a contract laboratory.  
P-210-01-2019 Mail/fax auditing procedures for a contract laboratory.  
Process Optimization Batch  
P-215-01-2019 Documentation requirements for a Process Optimization Batch  
P-216-01-2019 LOD Qualification during Process Optimization  
P-217-01-2019 Tablet lubricant Qualification during Process Optimization  
Process Qualification Batch   
P-220-01-2019 Documentation requirements for a Process Qualification Batch  
P-225-01-2019 Side by side comparison for Process Qualification and Pivotal Batch  
P-230-01-2019 Granule Content Uniformity Qualification  
P-235-01-2019 Tablet Hardness Qualification  
Scale-Up and TTD   
P-240-01-2019 Preparing the scale-up report for pivotal batch manufacturing  
P-245-01-2019 Check list of a TTD file  
Pivotal Batch   
P-250-01-2019 Pivotal Batch requirements  
P-252-01-2019 In-process sampling & testing procedures of tablets, caplets and capsules for pivotal batches  
P-255-01-2019 Do's and Don'ts when preparing for pivotal batches  
P-260-01-2019 Check list for Pivotal Batch Documentation  
P-265-01-2019 Side by side comparison for Pivotal and Validation Batch  
P-270-01-2019 Do's and Don'ts when preparing for pivotal Biostudies  
P-275-01-2019 Dissolution requirements for Biostudies  
P-280-01-2019 Dissolution Testing for Solid Oral Dosage Forms  
P-282-01-2019 Dissolution Testing for Suspended Oral Dosage Forms  
P-283-01-2019 Check List & Documentation for and IVIVC/Pilot Study  
P-285-01-2019 Check List for Biostudy Documentation  
P-290-01-2019 Good House Keeping Practice in a Small Scale Development Unit  
P-295-01-2019 Cleaning and Sanitation Procedures for Small Scale Development Unit  
P-300-01-2019 Validation of Cleaning procedures for Small Scale Manufacturing Equipment  
P-305-01-2019 Garmenting procedures for development personnel  
Chart Control  
P-310-01-2019 Routine signing and checking of temperature charts  
P-315-01-2019 Review & control of temperature & humidity recording charts  
Calibration, Validation and Qualification  
P-320-01-2019 Itemized List of Small Scale Development Equipment  
P-325-01-2019 IQ/OQ Requirements for Small Scale Manufacturing Equipment  
P-330-01-2019 Calibration Requirements for Small Scale Mfg. Equipment  
P-335-01-2019 Operational Instructions for Small Scale Mfg. Equipment  
P-340-01-2019 Annual qualification program for Small Scale Mfg. Equipment  
P-342-01-2019 Annual qualification program for Laboratory Equipment  
P-345-01-2019 Preventative maintenance for Small Scale Mfg. Equipment  
P-348-01-2019 Preventative maintenance for laboratory Analytical Equipment  
P-350-01-2019 Reserved SOPs for specialized equipment and test methods  
Contract Laboratories  
P-355-01-2019 Auditing procedures for a contract laboratory.  
P-360-01-2019 Mail / fax auditing procedures for a contract laboratory.  
Self-inspection and Auditing  
P-365-01-2019 Cross- referencing laboratory notebooks with computerized development report sheets.  
P-370-01-2019 Auditing development data in laboratory notebooks.  
P-375-01-2019 Self inspection procedures in a generic development Lab.  
Job descriptions and Training  
P-380-01-2019 Using Development SOPs and compliance program as training tools.  
P-385-01-2019 The do's and don'ts of a development study as a department training tool.  
P-390-01-2019 R&D Compliance Staff Training  
P-395-01-2019 Job description of Pharmaceutical R&D personnel  
P-400-01-2019 Operator Certification Procedures of Development Personnel  
P-405-01-2019 Maintenance of development personnel training records  
Reviewing Documentation  
P-410-01-2019 Review & Auditing Development Documentation.  
P-415-01-2019 Review & Auditing The Process Qualification Batch Documentation.  
P-420-01-2019 Review & Auditing The Pivotal Batch Documentation.  
Closing a Study  
P-425-01-2019 Accepting and signing-off a completed development study.  
Available to IAGIM members via IAGIM Center - 24 SOPs on IAGIM Online.  

-| -Analytical- | -Microbiological- | -Stability

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