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IAGIM - SOPs - Pharmaceutical
 

DRUG -DEVELOPMENT -SOPs
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-000-01-2016 Template for Pharmaceutical Development SOPs.  
P-005-01-2016 Indexing procedure for Pharmaceutical Development SOPs.  
P-010-01-2016 Index for Pharmaceutical Development SOPs.  
P-015-01-2016 Signing procedures for Pharmaceutical Development SOPs.  
P-021-02-2016 Numbering and format of Pharmaceutical Development SOPs.  
P-025-01-2016 Circulation of Pharmaceutical Development SOPs.  
P-030-01-2016 Annual Review of Pharmaceutical Development SOPs.  
   
Development Notebooks  
P-035-01-2016 Issue and use of pharmaceutical development notebooks  
P-040-01-2016 Signing procedures for development notebooks  

P-045-01-2016 Recording pre-formulation and development formula in development
notebooks.

 
P-051-02-2016 Recording manufacturing instruction in development notebooks  
P-055-01-2016 Recording IPQC specifications in development notebooks  
P-060-01-2016 Recording finished product specifications in development notebooks.  
P-065-01-2016 Review & auditing of pharmaceutical development notebooks  
P-070-01-2016 Correction procedures in development notebooks & documentation  
P-075-01-2016 Archiving of development notebooks. Development Quality Assurance  
P-080-01-2016 Procedures For Development Change Control Development Formula  
P-085-01-2016 Operating procedures for product development.  
P-090-01-2016 Formulation of ANDA topical preparations  
P-095-01-2016 Formulation of ANDAs to Q1Q2 Status (semi-solids)  
P-100-01-2016 Validation requirements for Product Development  
P-105-01-2016 Vendor Certification requirements for Product Development  
P-110-01-2016 Check list for a pharmaceutical development report  
P-115-01-2016 SOP for Development Reports  
   
Active Materials  
P-120-01-2016 Active Drug Substances for Generic Drugs  
P-125-01-2016 Developing Product Formula with approved Actives  
P-130-01-2016 R&D Inventory Records for the Active Drug Substance  
   
Semi-Active Raw Materials  
P-131-01-2016 Choosing the Antioxidant  
P-132-01-2016 Antioxidant Qualification during Process Optimization  
   
Non-Active materials   
P-140-01-2016 Non-active ingredients for ANDA formula development  
P-145-01-2016 Use of Purified Water USP in Product Development  
P-148-01-2016 Qualifying NON-active ingredients for ANDA manufacture.  
P-150-01-2016 Checking excipients in the FDA 'Inactive Ingredient Guide'  
   
Container-Liner-Closure Systems   
P-155-01-2016 Container-Liner-Closure systems for Generic Development  
P-160-01-2016 Documentation requirements for Container/Closure systems  
P-165-01-2016 Check list for Container-Liner-Closure Documents  
   
In-process Controls   
P-170-01-2016 Choice of IPQC limits. P-175-01-2016 Qualification of IPQC limits.  
P-180-01-2016 Qualification of manufacturing process specification limits.  
P-185-01-2016 In process control on bulk products  
P-190-01-2016 Time limitations on manufacturing processing stages  
   
Finished Product Controls  
P-195-01-2016 Choice of Finished Product Specification limits  
P-200-01-2016 Qualification of Finished Product Specification limits  
   
Contract Laboratories  
P-205-01-2016 Auditing procedures for a contract laboratory.  
P-210-01-2016 Mail/fax auditing procedures for a contract laboratory.  
   
Process Optimization Batch  
P-215-01-2016 Documentation requirements for a Process Optimization Batch  
P-216-01-2016 LOD Qualification during Process Optimization  
P-217-01-2016 Tablet lubricant Qualification during Process Optimization  
   
Process Qualification Batch   
P-220-01-2016 Documentation requirements for a Process Qualification Batch  
P-225-01-2016 Side by side comparison for Process Qualification and Pivotal Batch  
P-230-01-2016 Granule Content Uniformity Qualification  
P-235-01-2016 Tablet Hardness Qualification  
   
Scale-Up and TTD   
P-240-01-2016 Preparing the scale-up report for pivotal batch manufacturing  
P-245-01-2016 Check list of a TTD file  
   
Pivotal Batch   
P-250-01-2016 Pivotal Batch requirements  
P-252-01-2016 In-process sampling & testing procedures of tablets, caplets and capsules for pivotal batches  
P-255-01-2016 Do's and Don'ts when preparing for pivotal batches  
P-260-01-2016 Check list for Pivotal Batch Documentation  
P-265-01-2016 Side by side comparison for Pivotal and Validation Batch  
   
Biostudy  
P-270-01-2016 Do's and Don'ts when preparing for pivotal Biostudies  
P-275-01-2016 Dissolution requirements for Biostudies  
P-280-01-2016 Dissolution Testing for Solid Oral Dosage Forms  
P-282-01-2016 Dissolution Testing for Suspended Oral Dosage Forms  
P-283-01-2016 Check List & Documentation for and IVIVC/Pilot Study  
P-285-01-2016 Check List for Biostudy Documentation  
   
Sanitation  
P-290-01-2016 Good House Keeping Practice in a Small Scale Development Unit  
P-295-01-2016 Cleaning and Sanitation Procedures for Small Scale Development Unit  
P-300-01-2016 Validation of Cleaning procedures for Small Scale Manufacturing Equipment  
P-305-01-2016 Garmenting procedures for development personnel  
   
Chart Control  
P-310-01-2016 Routine signing and checking of temperature charts  
P-315-01-2016 Review & control of temperature & humidity recording charts  
   
Calibration, Validation and Qualification  
P-320-01-2016 Itemized List of Small Scale Development Equipment  
P-325-01-2016 IQ/OQ Requirements for Small Scale Manufacturing Equipment  
P-330-01-2016 Calibration Requirements for Small Scale Mfg. Equipment  
P-335-01-2016 Operational Instructions for Small Scale Mfg. Equipment  
P-340-01-2016 Annual qualification program for Small Scale Mfg. Equipment  
P-342-01-2016 Annual qualification program for Laboratory Equipment  
P-345-01-2016 Preventative maintenance for Small Scale Mfg. Equipment  
P-348-01-2016 Preventative maintenance for laboratory Analytical Equipment  
P-350-01-2016 Reserved SOPs for specialized equipment and test methods  
   
Contract Laboratories  
P-355-01-2016 Auditing procedures for a contract laboratory.  
P-360-01-2016 Mail / fax auditing procedures for a contract laboratory.  
   
Self-inspection and Auditing  
P-365-01-2016 Cross- referencing laboratory notebooks with computerized development report sheets.  
P-370-01-2016 Auditing development data in laboratory notebooks.  
P-375-01-2016 Self inspection procedures in a generic development Lab.  
   
Job descriptions and Training  
P-380-01-2016 Using Development SOPs and compliance program as training tools.  
P-385-01-2016 The do's and don'ts of a development study as a department training tool.  
P-390-01-2016 R&D Compliance Staff Training  
P-395-01-2016 Job description of Pharmaceutical R&D personnel  
P-400-01-2016 Operator Certification Procedures of Development Personnel  
P-405-01-2016 Maintenance of development personnel training records  
   
Reviewing Documentation  
P-410-01-2016 Review & Auditing Development Documentation.  
P-415-01-2016 Review & Auditing The Process Qualification Batch Documentation.  
P-420-01-2016 Review & Auditing The Pivotal Batch Documentation.  
   
Closing a Study  
P-425-01-2016 Accepting and signing-off a completed development study.  
   
Available to IAGIM members via IAGIM Center - 24 SOPs on IAGIM Online.  


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


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