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| 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) |
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| SOP
Control |
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| P-000-01-2009 Template for Pharmaceutical Development SOPs. |
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| P-005-01-2009 Indexing procedure for Pharmaceutical Development
SOPs. |
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| P-010-01-2009 Index for
Pharmaceutical Development SOPs. |
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| P-015-01-2009 Signing procedures for Pharmaceutical Development SOPs. |
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| P-020-01-2009 Numbering and format of Pharmaceutical Development
SOPs. |
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| P-025-01-2009 Circulation
of Pharmaceutical Development SOPs. |
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| P-030-01-2009 Annual Review of Pharmaceutical Development SOPs. |
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| Development
Notebooks |
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| P-035-01-2009 Issue and use of pharmaceutical development notebooks |
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| P-040-01-2009 Signing procedures for development notebooks
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| P-045-01-2009 Recording pre-formulation and development formula in development
notebooks.
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| P-050-01-2009 Recording manufacturing instruction in development notebooks |
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| P-055-01-2009 Recording IPQC specifications in development
notebooks |
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| P-060-01-2009 Recording
finished product specifications in development notebooks. |
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| P-065-01-2009 Review & auditing of pharmaceutical development
notebooks |
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| P-070-01-2009 Correction
procedures in development notebooks & documentation |
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| P-075-01-2009 Archiving of development notebooks. Development
Quality Assurance |
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| P-080-01-2009 Procedures For Development Change Control Development Formula |
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| P-085-01-2009 Operating procedures for product development.
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| P-090-01-2009 Formulation
of ANDA topical preparations |
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| P-095-01-2009 Formulation of ANDAs to Q1Q2 Status
(semi-solids) |
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| P-100-01-2009 Validation requirements for Product Development
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| P-105-01-2009 Vendor Certification
requirements for Product Development |
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| P-110-01-2009 Check list for a pharmaceutical development report |
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| P-115-01-2009 SOP for Development Reports |
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| Active
Materials |
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| P-120-01-2009 Active Drug Substances for Generic Drugs |
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| P-125-01-2009 Developing Product Formula with approved Actives |
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| P-130-01-2009 R&D Inventory Records for the Active Drug Substance |
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| Semi-Active
Raw Materials |
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| P-131-01-2009 Choosing the Antioxidant |
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| P-132-01-2009 Antioxidant Qualification during Process Optimization |
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| Non-Active
materials |
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| P-140-01-2009 Non-active ingredients for ANDA formula development
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| P-145-01-2009 Use of Purified
Water USP in Product Development |
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| P-148-01-2009 Qualifying NON-active ingredients for ANDA manufacture. |
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| P-150-01-2009 Checking excipients in the FDA 'Inactive Ingredient
Guide' |
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| Container-Liner-Closure Systems
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| P-155-01-2009 Container-Liner-Closure
systems for Generic Development |
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| P-160-01-2009 Documentation requirements for Container/Closure systems |
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| P-165-01-2009 Check list for Container-Liner-Closure Documents
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| In-process Controls
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| P-170-01-2009 Choice
of IPQC limits. P-175-01-2009 Qualification of IPQC limits. |
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| P-180-01-2009 Qualification of manufacturing process specification
limits. |
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| P-185-01-2009 In process
control on bulk products |
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| P-190-01-2009 Time limitations on manufacturing processing stages |
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| Finished
Product Controls |
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| P-195-01-2009 Choice of Finished Product Specification limits |
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| P-200-01-2009 Qualification of Finished Product Specification
limits |
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| Contract Laboratories
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| P-205-01-2009 Auditing procedures
for a contract laboratory. |
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| P-210-01-2009 Mail/fax auditing procedures for a contract laboratory. |
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| Process
Optimization Batch |
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| P-215-01-2009 Documentation requirements for a Process Optimization Batch |
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| P-216-01-2009 LOD Qualification during Process Optimization |
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| P-217-01-2009 Tablet lubricant Qualification during Process
Optimization |
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| Process Qualification Batch
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| P-220-01-2009 Documentation
requirements for a Process Qualification Batch |
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| P-225-01-2009 Side by side comparison for Process Qualification
and Pivotal Batch |
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| P-230-01-2009 Granule Content Uniformity Qualification |
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| P-235-01-2009 Tablet Hardness Qualification |
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| Scale-Up and TTD
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| P-240-01-2009 Preparing
the scale-up report for pivotal batch manufacturing |
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| P-245-01-2009 Check list of a TTD file |
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| Pivotal
Batch |
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| P-250-01-2009 Pivotal Batch requirements |
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| P-252-01-2009 In-process sampling & testing procedures of
tablets, caplets and capsules for pivotal batches |
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| P-255-01-2009 Do's and Don'ts when preparing for pivotal
batches |
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| P-260-01-2009 Check
list for Pivotal Batch Documentation |
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| P-265-01-2009 Side by side comparison for Pivotal and Validation Batch |
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| Biostudy
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| P-270-01-2009 Do's
and Don'ts when preparing for pivotal Biostudies |
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| P-275-01-2009 Dissolution requirements for Biostudies |
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| P-280-01-2009 Dissolution Testing for Solid Oral Dosage Forms
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| P-282-01-2009 Dissolution
Testing for Suspended Oral Dosage Forms |
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P-283-01-2009 Check List & Documentation for and IVIVC/Pilot Study |
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| P-285-01-2009 Check List for Biostudy Documentation |
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| Sanitation |
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| P-290-01-2009 Good House Keeping Practice in a Small Scale
Development Unit |
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P-295-01-2009 Cleaning and Sanitation Procedures for Small Scale Development Unit |
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| P-300-01-2009 Validation of Cleaning procedures for Small
Scale Manufacturing Equipment |
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| P-305-01-2009 Garmenting procedures for development personnel |
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| Chart
Control |
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| P-310-01-2009 Routine signing and checking of temperature charts |
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| P-315-01-2009 Review & control of temperature & humidity
recording charts |
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| Calibration, Validation and
Qualification |
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| P-320-01-2009 Itemized List of Small Scale Development Equipment |
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| P-325-01-2009 IQ/OQ Requirements for Small Scale Manufacturing
Equipment |
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| P-330-01-2009 Calibration
Requirements for Small Scale Mfg. Equipment |
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| P-335-01-2009 Operational Instructions for Small Scale Mfg. Equipment |
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| P-340-01-2009 Annual qualification program for Small Scale
Mfg. Equipment |
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| P-342-01-2009 Annual qualification program for Laboratory Equipment |
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| P-345-01-2009 Preventative maintenance for Small Scale Mfg.
Equipment |
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| P-348-01-2009 Preventative
maintenance for laboratory Analytical Equipment |
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| P-350-01-2009 Reserved SOPs for specialized equipment and
test methods |
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| Contract Laboratories |
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| P-355-01-2009 Auditing procedures for a contract laboratory. |
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| P-360-01-2009 Mail / fax auditing procedures for a contract
laboratory. |
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| Self-inspection and Auditing
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| P-365-01-2009 Cross-
referencing laboratory notebooks with computerized development report sheets.
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| P-370-01-2009 Auditing development
data in laboratory notebooks. |
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| P-375-01-2009 Self inspection procedures in a generic development Lab. |
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| Job
descriptions and Training |
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| P-380-01-2009 Using Development SOPs and compliance program as training tools. |
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| P-385-01-2009 The do's and don'ts of a development study
as a department training tool. |
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| P-390-01-2009 R&D Compliance Staff Training |
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| P-395-01-2009 Job description of Pharmaceutical R&D personnel |
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| P-400-01-2009 Operator Certification Procedures of Development
Personnel |
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| P-405-01-2009 Maintenance
of development personnel training records |
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| Reviewing
Documentation |
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| P-410-01-2009 Review & Auditing Development
Documentation. |
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| P-415-01-2009 Review & Auditing The Process Qualification
Batch Documentation. |
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| P-420-01-2009 Review & Auditing The Pivotal
Batch Documentation. |
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| Closing
a Study |
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| P-425-01-2009 Accepting and signing-off a completed development study. |
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Available
to IAGIM members via IAGIM Center - 24 SOPs on IAGIM Online.
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