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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-000-01-2008 Template for Pharmaceutical Development SOPs. |
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| P-005-01-2008 Indexing procedure for Pharmaceutical Development
SOPs. |
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| P-010-01-2008 Index for
Pharmaceutical Development SOPs. |
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| P-015-01-2008 Signing procedures for Pharmaceutical Development SOPs. |
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| P-020-01-2008 Numbering and format of Pharmaceutical Development
SOPs. |
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| P-025-01-2008 Circulation
of Pharmaceutical Development SOPs. |
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| P-030-01-2008 Annual Review of Pharmaceutical Development SOPs. |
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| Development
Notebooks |
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| P-035-01-2008 Issue and use of pharmaceutical development notebooks |
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| P-040-01-2008 Signing procedures for development notebooks
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| P-045-01-2008 Recording pre-formulation and development formula in development
notebooks.
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| P-050-01-2008 Recording manufacturing instruction in development notebooks |
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| P-055-01-2008 Recording IPQC specifications in development
notebooks |
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| P-060-01-2008 Recording
finished product specifications in development notebooks. |
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| P-065-01-2008 Review & auditing of pharmaceutical development
notebooks |
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| P-070-01-2008 Correction
procedures in development notebooks & documentation |
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| P-075-01-2008 Archiving of development notebooks. Development
Quality Assurance |
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| P-080-01-2008 Procedures For Development Change Control Development Formula |
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| P-085-01-2008 Operating procedures for product development.
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| P-090-01-2008 Formulation
of ANDA topical preparations |
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| P-095-01-2008 Formulation of ANDAs to Q1Q2 Status
(semi-solids) |
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| P-100-01-2008 Validation requirements for Product Development
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| P-105-01-2008 Vendor Certification
requirements for Product Development |
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| P-110-01-2008 Check list for a pharmaceutical development report |
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| P-115-01-2008 SOP for Development Reports |
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| Active
Materials |
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| P-120-01-2008 Active Drug Substances for Generic Drugs |
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| P-125-01-2008 Developing Product Formula with approved Actives |
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| P-130-01-2008 R&D Inventory Records for the Active Drug Substance |
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| Semi-Active
Raw Materials |
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| P-131-01-2008 Choosing the Antioxidant |
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| P-132-01-2008 Antioxidant Qualification during Process Optimization |
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| Non-Active
materials |
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| P-140-01-2008 Non-active ingredients for ANDA formula development
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| P-145-01-2008 Use of Purified
Water USP in Product Development |
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| P-148-01-2008 Qualifying NON-active ingredients for ANDA manufacture. |
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| P-150-01-2008 Checking excipients in the FDA 'Inactive Ingredient
Guide' |
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| Container-Liner-Closure Systems
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| P-155-01-2008 Container-Liner-Closure
systems for Generic Development |
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| P-160-01-2008 Documentation requirements for Container/Closure systems |
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| P-165-01-2008 Check list for Container-Liner-Closure Documents
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| In-process Controls
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| P-170-01-2008 Choice
of IPQC limits. P-175-01-2008 Qualification of IPQC limits. |
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| P-180-01-2008 Qualification of manufacturing process specification
limits. |
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| P-185-01-2008 In process
control on bulk products |
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| P-190-01-2008 Time limitations on manufacturing processing stages |
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| Finished
Product Controls |
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| P-195-01-2008 Choice of Finished Product Specification limits |
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| P-200-01-2008 Qualification of Finished Product Specification
limits |
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| Contract Laboratories
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| P-205-01-2008 Auditing procedures
for a contract laboratory. |
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| P-210-01-2008 Mail/fax auditing procedures for a contract laboratory. |
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| Process
Optimization Batch |
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| P-215-01-2008 Documentation requirements for a Process Optimization Batch |
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| P-216-01-2008 LOD Qualification during Process Optimization |
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| P-217-01-2008 Tablet lubricant Qualification during Process
Optimization |
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| Process Qualification Batch
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| P-220-01-2008 Documentation
requirements for a Process Qualification Batch |
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| P-225-01-2008 Side by side comparison for Process Qualification
and Pivotal Batch |
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| P-230-01-2008 Granule Content Uniformity Qualification |
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| P-235-01-2008 Tablet Hardness Qualification |
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| Scale-Up and TTD
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| P-240-01-2008 Preparing
the scale-up report for pivotal batch manufacturing |
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| P-245-01-2008 Check list of a TTD file |
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| Pivotal
Batch |
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| P-250-01-2008 Pivotal Batch requirements |
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| P-252-01-2008 In-process sampling & testing procedures of
tablets, caplets and capsules for pivotal batches |
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| P-255-01-2008 Do's and Don'ts when preparing for pivotal
batches |
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| P-260-01-2008 Check
list for Pivotal Batch Documentation |
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| P-265-01-2008 Side by side comparison for Pivotal and Validation Batch |
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| Biostudy
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| P-270-01-2008 Do's
and Don'ts when preparing for pivotal Biostudies |
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| P-275-01-2008 Dissolution requirements for Biostudies |
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| P-280-01-2008 Dissolution Testing for Solid Oral Dosage Forms
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| P-282-01-2008 Dissolution
Testing for Suspended Oral Dosage Forms |
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P-283-01-2008 Check List & Documentation for and IVIVC/Pilot Study |
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| P-285-01-2008 Check List for Biostudy Documentation |
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| Sanitation |
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| P-290-01-2008 Good House Keeping Practice in a Small Scale
Development Unit |
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P-295-01-2008 Cleaning and Sanitation Procedures for Small Scale Development Unit |
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| P-300-01-2008 Validation of Cleaning procedures for Small
Scale Manufacturing Equipment |
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| P-305-01-2008 Garmenting procedures for development personnel |
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| Chart
Control |
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| P-310-01-2008 Routine signing and checking of temperature charts |
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| P-315-01-2008 Review & control of temperature & humidity
recording charts |
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| Calibration, Validation and
Qualification |
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| P-320-01-2008 Itemized List of Small Scale Development Equipment |
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| P-325-01-2008 IQ/OQ Requirements for Small Scale Manufacturing
Equipment |
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| P-330-01-2008 Calibration
Requirements for Small Scale Mfg. Equipment |
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| P-335-01-2008 Operational Instructions for Small Scale Mfg. Equipment |
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| P-340-01-2008 Annual qualification program for Small Scale
Mfg. Equipment |
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| P-342-01-2008 Annual qualification program for Laboratory Equipment |
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| P-345-01-2008 Preventative maintenance for Small Scale Mfg.
Equipment |
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| P-348-01-2008 Preventative
maintenance for laboratory Analytical Equipment |
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| P-350-01-2008 Reserved SOPs for specialized equipment and
test methods |
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| Contract Laboratories |
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| P-355-01-2008 Auditing procedures for a contract laboratory. |
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| P-360-01-2008 Mail / fax auditing procedures for a contract
laboratory. |
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| Self-inspection and Auditing
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| P-365-01-2008 Cross-
referencing laboratory notebooks with computerized development report sheets.
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| P-370-01-2008 Auditing development
data in laboratory notebooks. |
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| P-375-01-2008 Self inspection procedures in a generic development Lab. |
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| Job
descriptions and Training |
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| P-380-01-2008 Using Development SOPs and compliance program as training tools. |
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| P-385-01-2008 The do's and don'ts of a development study
as a department training tool. |
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| P-390-01-2008 R&D Compliance Staff Training |
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| P-395-01-2008 Job description of Pharmaceutical R&D personnel |
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| P-400-01-2008 Operator Certification Procedures of Development
Personnel |
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| P-405-01-2008 Maintenance
of development personnel training records |
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| Reviewing
Documentation |
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| P-410-01-2008 Review & Auditing Development
Documentation. |
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| P-415-01-2008 Review & Auditing The Process Qualification
Batch Documentation. |
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| P-420-01-2008 Review & Auditing The Pivotal
Batch Documentation. |
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| Closing
a Study |
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| P-425-01-2008 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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