SEARCH
IAGIM - Drug Development Association

IAGIM - SOPs - Pharmaceutical


DRUG DEVELOPMENT SOPs

" High Quality Cost Effective Drug Development & Manufacturing Excellence World Wide "... .
Archive of SOPs - Pharmaceutical
Pharmaceutical | Analytical | Microbiological | Stability

IAGIM Members - Free SOPs on IAGIM Online
To Purchase SOP CD ROM - VIEW


Download an Example SOP and Another One - Just to See
   
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-000-01-2008 Template for Pharmaceutical Development SOPs.  
P-005-01-2008 Indexing procedure for Pharmaceutical Development SOPs.  
P-010-01-2008 Index for Pharmaceutical Development SOPs.  
P-015-01-2008 Signing procedures for Pharmaceutical Development SOPs.  
P-020-01-2008 Numbering and format of Pharmaceutical Development SOPs.  
P-025-01-2008 Circulation of Pharmaceutical Development SOPs.  
P-030-01-2008 Annual Review of Pharmaceutical Development SOPs.  
   
Development Notebooks  
P-035-01-2008 Issue and use of pharmaceutical development notebooks  
P-040-01-2008 Signing procedures for development notebooks  

P-045-01-2008 Recording pre-formulation and development formula in development
notebooks.

 
P-050-01-2008 Recording manufacturing instruction in development notebooks  
P-055-01-2008 Recording IPQC specifications in development notebooks  
P-060-01-2008 Recording finished product specifications in development notebooks.  
P-065-01-2008 Review & auditing of pharmaceutical development notebooks  
P-070-01-2008 Correction procedures in development notebooks & documentation  
P-075-01-2008 Archiving of development notebooks. Development Quality Assurance  
P-080-01-2008 Procedures For Development Change Control Development Formula  
P-085-01-2008 Operating procedures for product development.  
P-090-01-2008 Formulation of ANDA topical preparations  
P-095-01-2008 Formulation of ANDAs to Q1Q2 Status (semi-solids)  
P-100-01-2008 Validation requirements for Product Development  
P-105-01-2008 Vendor Certification requirements for Product Development  
P-110-01-2008 Check list for a pharmaceutical development report  
P-115-01-2008 SOP for Development Reports  
   
Active Materials  
P-120-01-2008 Active Drug Substances for Generic Drugs  
P-125-01-2008 Developing Product Formula with approved Actives  
P-130-01-2008 R&D Inventory Records for the Active Drug Substance  
   
Semi-Active Raw Materials  
P-131-01-2008 Choosing the Antioxidant  
P-132-01-2008 Antioxidant Qualification during Process Optimization  
   
Non-Active materials  
P-140-01-2008 Non-active ingredients for ANDA formula development  
P-145-01-2008 Use of Purified Water USP in Product Development  
P-148-01-2008 Qualifying NON-active ingredients for ANDA manufacture.  
P-150-01-2008 Checking excipients in the FDA 'Inactive Ingredient Guide'  
   
Container-Liner-Closure Systems  
P-155-01-2008 Container-Liner-Closure systems for Generic Development  
P-160-01-2008 Documentation requirements for Container/Closure systems  
P-165-01-2008 Check list for Container-Liner-Closure Documents  
   
In-process Controls  
P-170-01-2008 Choice of IPQC limits. P-175-01-2008 Qualification of IPQC limits.  
P-180-01-2008 Qualification of manufacturing process specification limits.  
P-185-01-2008 In process control on bulk products  
P-190-01-2008 Time limitations on manufacturing processing stages  
   
Finished Product Controls  
P-195-01-2008 Choice of Finished Product Specification limits  
P-200-01-2008 Qualification of Finished Product Specification limits  
   
Contract Laboratories  
P-205-01-2008 Auditing procedures for a contract laboratory.  
P-210-01-2008 Mail/fax auditing procedures for a contract laboratory.  
   
Process Optimization Batch  
P-215-01-2008 Documentation requirements for a Process Optimization Batch  
P-216-01-2008 LOD Qualification during Process Optimization  
P-217-01-2008 Tablet lubricant Qualification during Process Optimization  
   
Process Qualification Batch  
P-220-01-2008 Documentation requirements for a Process Qualification Batch  
P-225-01-2008 Side by side comparison for Process Qualification and Pivotal Batch  
P-230-01-2008 Granule Content Uniformity Qualification  
P-235-01-2008 Tablet Hardness Qualification  
   
Scale-Up and TTD  
P-240-01-2008 Preparing the scale-up report for pivotal batch manufacturing  
P-245-01-2008 Check list of a TTD file  
   
Pivotal Batch  
P-250-01-2008 Pivotal Batch requirements  
P-252-01-2008 In-process sampling & testing procedures of tablets, caplets and capsules for pivotal batches  
P-255-01-2008 Do's and Don'ts when preparing for pivotal batches  
P-260-01-2008 Check list for Pivotal Batch Documentation  
P-265-01-2008 Side by side comparison for Pivotal and Validation Batch  
   
Biostudy  
P-270-01-2008 Do's and Don'ts when preparing for pivotal Biostudies  
P-275-01-2008 Dissolution requirements for Biostudies  
P-280-01-2008 Dissolution Testing for Solid Oral Dosage Forms  
P-282-01-2008 Dissolution Testing for Suspended Oral Dosage Forms  
P-283-01-2008 Check List & Documentation for and IVIVC/Pilot Study  
P-285-01-2008 Check List for Biostudy Documentation  
   
Sanitation  
P-290-01-2008 Good House Keeping Practice in a Small Scale Development Unit  
P-295-01-2008 Cleaning and Sanitation Procedures for Small Scale Development Unit  
P-300-01-2008 Validation of Cleaning procedures for Small Scale Manufacturing Equipment  
P-305-01-2008 Garmenting procedures for development personnel  
   
Chart Control  
P-310-01-2008 Routine signing and checking of temperature charts  
P-315-01-2008 Review & control of temperature & humidity recording charts  
   
Calibration, Validation and Qualification  
P-320-01-2008 Itemized List of Small Scale Development Equipment  
P-325-01-2008 IQ/OQ Requirements for Small Scale Manufacturing Equipment  
P-330-01-2008 Calibration Requirements for Small Scale Mfg. Equipment  
P-335-01-2008 Operational Instructions for Small Scale Mfg. Equipment  
P-340-01-2008 Annual qualification program for Small Scale Mfg. Equipment  
P-342-01-2008 Annual qualification program for Laboratory Equipment  
P-345-01-2008 Preventative maintenance for Small Scale Mfg. Equipment  
P-348-01-2008 Preventative maintenance for laboratory Analytical Equipment  
P-350-01-2008 Reserved SOPs for specialized equipment and test methods  
   
Contract Laboratories  
P-355-01-2008 Auditing procedures for a contract laboratory.  
P-360-01-2008 Mail / fax auditing procedures for a contract laboratory.  
   
Self-inspection and Auditing  
P-365-01-2008 Cross- referencing laboratory notebooks with computerized development report sheets.  
P-370-01-2008 Auditing development data in laboratory notebooks.  
P-375-01-2008 Self inspection procedures in a generic development Lab.  
   
Job descriptions and Training  
P-380-01-2008 Using Development SOPs and compliance program as training tools.  
P-385-01-2008 The do's and don'ts of a development study as a department training tool.  
P-390-01-2008 R&D Compliance Staff Training  
P-395-01-2008 Job description of Pharmaceutical R&D personnel  
P-400-01-2008 Operator Certification Procedures of Development Personnel  
P-405-01-2008 Maintenance of development personnel training records  
   
Reviewing Documentation  
P-410-01-2008 Review & Auditing Development Documentation.  
P-415-01-2008 Review & Auditing The Process Qualification Batch Documentation.  
P-420-01-2008 Review & Auditing The Pivotal Batch Documentation.  
   
Closing a Study  
P-425-01-2008 Accepting and signing-off a completed development study.  
   
Available to IAGIM members via IAGIM Center - 24 SOPs on IAGIM Online.
 


Pharmaceutical | Analytical | Microbiological | Stability


Download an Example SOP and Another One - Just to See


IAGIM ONLINE LOGIN
E-mailPassword


| Shipping |
By FastTrack | Using Credit Cards | Making Payments | Global Agents | Data Protection |
|
Fast Service | Western Union | Press Reports | Int. J. of Food & Wine cGMP | Download Online Invoices

Copyright LIG © 2008 Locum International Inc. All Rights Reserved.
Read our Terms & Conditions of Use
- |

INTERNATIONA 24 x 7 FAX -| - + 972-50-896-5523 - - | - - US 24 x 7 FAX : - 1-561-431-2620