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" High Quality Cost Effective
Drug Development & Manufacturing Excellence World Wide "
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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-000-01-2019 Template for Pharmaceutical Development
SOPs. |
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| P-005-01-2019 Indexing procedure for Pharmaceutical
Development SOPs. |
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| P-010-01-2019 Index for Pharmaceutical Development
SOPs. |
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| P-015-01-2019 Signing procedures for Pharmaceutical
Development SOPs. |
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| P-021-02-2019 Numbering and format of Pharmaceutical
Development SOPs. |
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| P-025-01-2019 Circulation of Pharmaceutical Development
SOPs. |
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| P-030-01-2019 Annual Review of Pharmaceutical
Development SOPs. |
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| Development Notebooks
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| P-035-01-2019 Issue and use of pharmaceutical
development notebooks |
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| P-040-01-2019 Signing procedures for development
notebooks |
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P-045-01-2019 Recording pre-formulation and development formula
in development
notebooks.
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| P-051-02-2019 Recording manufacturing instruction
in development notebooks |
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| P-055-01-2019 Recording IPQC specifications in
development notebooks |
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| P-060-01-2019 Recording finished product specifications
in development notebooks. |
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| P-065-01-2019 Review & auditing of pharmaceutical
development notebooks |
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| P-070-01-2019 Correction procedures in development
notebooks & documentation |
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| P-075-01-2019 Archiving of development notebooks.
Development Quality Assurance |
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| P-080-01-2019 Procedures For Development Change
Control Development Formula |
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| P-085-01-2019 Operating procedures for product
development. |
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| P-090-01-2019 Formulation of ANDA topical preparations
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| P-095-01-2019 Formulation of ANDAs to Q1Q2 Status
(semi-solids) |
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| P-100-01-2019 Validation requirements for Product
Development |
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| P-105-01-2019 Vendor Certification requirements
for Product Development |
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| P-110-01-2019 Check list for a pharmaceutical
development report |
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| P-115-01-2019 SOP for Development Reports |
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| Active Materials |
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| P-120-01-2019 Active Drug Substances for Generic
Drugs |
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| P-125-01-2019 Developing Product Formula with
approved Actives |
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| P-130-01-2019 R&D Inventory Records for the Active
Drug Substance |
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| Semi-Active Raw Materials
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| P-131-01-2019 Choosing the Antioxidant |
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| P-132-01-2019 Antioxidant Qualification during
Process Optimization |
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| Non-Active materials
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| P-140-01-2019 Non-active ingredients for ANDA
formula development |
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| P-145-01-2019 Use of Purified Water USP in Product
Development |
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| P-148-01-2019 Qualifying NON-active ingredients
for ANDA manufacture. |
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| P-150-01-2019 Checking excipients in the FDA 'Inactive
Ingredient Guide' |
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| Container-Liner-Closure
Systems |
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| P-155-01-2019 Container-Liner-Closure systems
for Generic Development |
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| P-160-01-2019 Documentation requirements for Container/Closure
systems |
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| P-165-01-2019 Check list for Container-Liner-Closure
Documents |
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| In-process Controls
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| P-170-01-2019 Choice of IPQC limits. P-175-01-2019
Qualification of IPQC limits. |
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| P-180-01-2019 Qualification of manufacturing process
specification limits. |
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| P-185-01-2019 In process control on bulk products
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| P-190-01-2019 Time limitations on manufacturing
processing stages |
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| Finished Product
Controls |
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| P-195-01-2019 Choice of Finished Product Specification
limits |
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| P-200-01-2019 Qualification of Finished Product
Specification limits |
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| Contract Laboratories
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| P-205-01-2019 Auditing procedures for a contract
laboratory. |
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| P-210-01-2019 Mail/fax auditing procedures for
a contract laboratory. |
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| Process Optimization
Batch |
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| P-215-01-2019 Documentation requirements for a
Process Optimization Batch |
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| P-216-01-2019 LOD Qualification during Process
Optimization |
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| P-217-01-2019 Tablet lubricant Qualification during
Process Optimization |
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| Process Qualification
Batch |
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| P-220-01-2019 Documentation requirements for a
Process Qualification Batch |
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| P-225-01-2019 Side by side comparison for Process
Qualification and Pivotal Batch |
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| P-230-01-2019 Granule Content Uniformity Qualification |
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| P-235-01-2019 Tablet Hardness Qualification |
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| Scale-Up and TTD
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| P-240-01-2019 Preparing the scale-up report for
pivotal batch manufacturing |
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| P-245-01-2019 Check list of a TTD file |
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| Pivotal Batch
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| P-250-01-2019 Pivotal Batch requirements |
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| P-252-01-2019 In-process sampling & testing procedures
of tablets, caplets and capsules for pivotal batches |
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| P-255-01-2019 Do's and Don'ts when preparing for
pivotal batches |
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| P-260-01-2019 Check list for Pivotal Batch Documentation
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| P-265-01-2019 Side by side comparison for Pivotal
and Validation Batch |
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| Biostudy
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| P-270-01-2019 Do's and Don'ts when preparing for
pivotal Biostudies |
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| P-275-01-2019 Dissolution requirements for Biostudies
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| P-280-01-2019 Dissolution Testing for Solid Oral
Dosage Forms |
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| P-282-01-2019 Dissolution Testing for Suspended
Oral Dosage Forms |
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| P-283-01-2019 Check List & Documentation
for and IVIVC/Pilot Study |
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| P-285-01-2019 Check List for Biostudy Documentation |
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| Sanitation |
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| P-290-01-2019 Good House Keeping Practice in
a Small Scale Development Unit |
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| P-295-01-2019 Cleaning and Sanitation
Procedures for Small Scale Development Unit |
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| P-300-01-2019 Validation of Cleaning procedures
for Small Scale Manufacturing Equipment |
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| P-305-01-2019 Garmenting procedures for development
personnel |
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| Chart Control
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| P-310-01-2019 Routine signing and checking of
temperature charts |
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| P-315-01-2019 Review & control of temperature
& humidity recording charts |
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| Calibration, Validation
and Qualification |
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| P-320-01-2019 Itemized List of Small Scale Development
Equipment |
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| P-325-01-2019 IQ/OQ Requirements for Small Scale
Manufacturing Equipment |
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| P-330-01-2019 Calibration Requirements for Small
Scale Mfg. Equipment |
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| P-335-01-2019 Operational Instructions for Small
Scale Mfg. Equipment |
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| P-340-01-2019 Annual qualification program for
Small Scale Mfg. Equipment |
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| P-342-01-2019 Annual qualification program for
Laboratory Equipment |
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| P-345-01-2019 Preventative maintenance for Small
Scale Mfg. Equipment |
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| P-348-01-2019 Preventative maintenance for laboratory
Analytical Equipment |
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| P-350-01-2019 Reserved SOPs for specialized equipment
and test methods |
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| Contract Laboratories
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| P-355-01-2019 Auditing procedures for a contract
laboratory. |
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| P-360-01-2019 Mail / fax auditing procedures for
a contract laboratory. |
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| Self-inspection and
Auditing |
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| P-365-01-2019 Cross- referencing laboratory notebooks
with computerized development report sheets. |
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| P-370-01-2019 Auditing development data in laboratory
notebooks. |
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| P-375-01-2019 Self inspection procedures in a
generic development Lab. |
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| Job descriptions
and Training |
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| P-380-01-2019 Using Development SOPs and compliance
program as training tools. |
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| P-385-01-2019 The do's and don'ts of a development
study as a department training tool. |
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| P-390-01-2019 R&D Compliance Staff Training |
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| P-395-01-2019 Job description of Pharmaceutical
R&D personnel |
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| P-400-01-2019 Operator Certification Procedures
of Development Personnel |
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| P-405-01-2019 Maintenance of development personnel
training records |
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| Reviewing Documentation
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| P-410-01-2019 Review & Auditing Development
Documentation. |
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| P-415-01-2019 Review & Auditing The Process
Qualification Batch Documentation. |
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| P-420-01-2019 Review & Auditing The Pivotal
Batch Documentation. |
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| Closing a Study |
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| P-425-01-2019 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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