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

Non members 330 + Key Selected e-SOPs on CD - View

an Example SOP and Another
One - Just to See

e-SOPs updated annually during December
The following SOP Index represents a reasonably adequate set of standard operating procedures for a development department to function efficiently. The development and control principles described in the standard operating procedures (+500) are required to conduct any development study (both NDA and Generic ANDA/AADA) to meet FDA / EC regulatory and compliance requirements and manage an efficient development study using standardized procedures. Specific development test method SOPs are not characterized in this list.  
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-020-01-2016 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

P-050-01-2016 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  
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  
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 And Auditing Development Documentation.  
P-415-01-2016 Review And Auditing The Process Qualification Batch Documentation.  
P-420-01-2016 Review And Auditing The Pivotal Batch Documentation.  
Closing a Study  
P-425-01-2016 Accepting and signing-off a completed development study.  


| Analytical | Microbiological | Stability
| Stability Summaries

| About Locum USA | About Locum International Group | About Locum Euro | Home | Contact |
| Wordwide Websites | SOPs
| Assays | Drug List | New Projects | HowToPay |

| LocumUSA | LocumEURO | IAGIM | Drug Development Workshops | Distance Learning Programs |

CONTACT VIA EMAIL -| - CALL +561 865 6147