DRUG DEVELOPMENT SOPs
" High Quality Cost Effective Drug Development & Manufacturing Excellence World Wide "... .
Archive of SOPs - Pharmaceutical
Non members 330 + Key Selected e-SOPs on CD - View
DRUG DEVELOPMENT SOPs
" High Quality Cost Effective Drug Development
& Manufacturing Excellence World Wide "... .
Archive of SOPs
- Pharmaceutical
Non
members 330 + Key Selected e-SOPs on CD
- View
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Download an Example SOP and Another One - Just to See |
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e-SOPs updated annually during
December
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| 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 | |
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P-045-01-2016 Recording pre-formulation and development formula in
development |
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| 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 | |
| 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 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. | |
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