PharmDocs Store
We offer ready-to-use dossiers, active MAs, out-licensing, and downloadable templates including checklists and regulatory documents as well as regulatory solutions to streamline your market entry and portfolio development.
Quality Management System
QMS – core SOP set
-
Document and Record Control SOP
3 000 Skr -
Training and Personnel Competence Management SOP
3 500 Skr -
Deviation and Non-Conformance Management SOP
3 000 Skr -
Corrective and Preventive Action (CAPA) Management SOP
3 200 Skr -
Change Control Management SOP
3 000 Skr -
Quality Risk Management SOP (ICH Q9)
3 800 Skr -
Internal Audit and Self-Inspection Programme SOP
3 200 Skr -
Management Review of the Pharmaceutical Quality System SOP
2 800 Skr -
Data Integrity and ALCOA+ Governance SOP
4 000 Skr -
Supplier Qualification and Oversight SOP
4 500 Skr -
Complete Quality Management System Documentation Package (Draft Framework)
38 500 Skr
GDP (Good Distribution Practice)
Warehousing & logistics
-
GDP – Quality System Manual Regulatory Mapping (EU GDP 2013/C 343/01)
4 000 Skr -
Responsible Person (RP) Roles and Responsibilities SOP
2 800 Skr -
Cold Chain and Temperature Control Management SOP
4 000 Skr -
Receipt, Quarantine, and Release of Medicinal Products SOP
2 600 Skr -
Storage and Stock Control of Medicinal Products SOP
2 800 Skr -
Picking, Packing, and Dispatch of Medicinal Products (EU GDP) SOP
2 600 Skr -
Transport Qualification and Shipping Oversight SOP
3 800 Skr -
Temperature Mapping of Storage and Distribution Areas, Protocol and Report
5 000 Skr -
Returns, Recalls, and Falsified Medicines Handling SOP
3 200 Skr -
Outsourced Activities and Contractual Oversight SOP
3 000 Skr -
Training – Wholesale Distribution Authorisation (WDA) Responsibilities and Oversight
2 000 Skr -
Training – Good Distribution Practice (GDP) Operational Management
2 000 Skr
Manufacturing/Production (GMP)
-
Master Batch Record (MBR) Framework Template
4 000 Skr -
Executed Batch Record (EBR) Documentation Framework Template
3 200 Skr -
Line Clearance and Batch Reconciliation SOP
2 800 Skr -
Cleaning and Sanitisation of Manufacturing Areas and Equipment SOP
3 000 Skr -
Preventive Maintenance and Calibration of Equipment and Instruments SOP
3 200 Skr -
Environmental Monitoring of Controlled Areas SOP
3 800 Skr -
Sampling of Raw Materials, Packaging Materials, and Finished Products SOP
2 800 Skr -
Out-of-Specification (OOS) and Out-of-Trend (OOT) Investigation Principles Training
4 000 Skr -
Training – Manufacturing Authorisation (MIA) Responsibilities and Oversight
2 000 Skr
Validation & Qualification
Annex 15 aligned
-
Validation Master Plan (VMP) Framework Template
5 000 Skr -
User Requirements Specification (URS) Framework Template
2 500 Skr -
Design Qualification (DQ) Framework Template
3 000 Skr -
Installation, Operational, and Performance Qualification (IQ/OQ/PQ) Protocols and Reports for Equipment (Template pack)
6 000 Skr -
Process Validation Protocol and Report (Stage 2 – Process Performance Qualification, PPQ) Template
5 000 Skr -
Cleaning Validation Protocol and Report Template
4 800 Skr -
Utilities Qualification Protocols (HVAC, PW/WFI, Compressed Air) Template
5 200 Skr -
GMP – SOP – Computerised System Validation and Assurance (CSV / CSA) Governance SOP
5 500 Skr -
Temperature Mapping Protocols for Storage and Transport Units Template
4 000 Skr
QC / Analytical
ICH-aligned
-
Analytical Method Lifecycle Management SOP
3 800 Skr -
Analytical Method Validation Protocol and Report Template (EU GMP / ICH Q2)
4 200 Skr -
Specifications for Active Substances, Drug Products, and Excipients Template
2 800 Skr -
Stability Study Protocol and Report Template
4 000 Skr -
Reference Standards and Sample Management SOP
2 800 Skr -
Trending and Control Charting Workbook
2 500 Skr
Training packs
Editable PPT + Facilitator notes + Quiz
-
GMP Fundamentals Overview Training (EU GMP and 21 CFR 210/211 Comparison)
2 000 Skr -
Data Integrity and ALCOA+ Principles Training
2 000 Skr -
Deviation and CAPA Best Practices Training
2 000 Skr -
Qualification and Validation Essentials Training (EU GMP Annex 15)
2 000 Skr -
GDP Fundamentals (EU GDP) Training
2 000 Skr
Checklists, forms & trackers
-
EU GDP Audit Checklist
1 400 Skr -
EU GMP Audit checklist
1 400 Skr -
Responsible Person Daily and Weekly Activities Checklist
900 Skr -
Regulatory Dossier Due Diligence checklist.
1 600 Skr -
IRP Applications Review Checklist
1 200 Skr -
Falsified Medicines Directive (EU FMD) Audit Checklist
1 200 Skr -
Deviation, CAPA, and Change Control Forms
1 200 Skr -
Training Records and Competency Matrix Records
1 000 Skr -
Supplier Qualification Questionnaire
1 400 Skr -
Goods-in Inspection and Transport Damage Form
900 Skr -
Temperature Excursion Investigation and Stability Impact Assessment Forms
1 200 Skr -
Equipment Cleaning, Use, Calibration, and Maintenance logbooks
1 400 Skr -
Stability Pull Schedule and Sample Inventory Tracker
1 000 Skr -
Validation Traceability Matrix
1 200 Skr -
Risk assessment workbook (FMEA)
1 300 Skr
Miscellaneous
-
Document and Record Control SOP
3 000 Skr -
Training and Personnel Competence Management SOP
3 500 Skr -
GDP – Quality System Manual Regulatory Mapping (EU GDP 2013/C 343/01)
4 000 Skr -
Master Batch Record (MBR) Framework Template
4 000 Skr -
Validation Master Plan (VMP) Framework Template
5 000 Skr -
Analytical Method Lifecycle Management SOP
3 800 Skr -
CMC Change Impact Assessment Template (CTD Module 3)
3 200 Skr -
Adverse Event Intake and Reporting SOP
3 800 Skr -
Deviation and Non-Conformance Management SOP
3 000 Skr -
Corrective and Preventive Action (CAPA) Management SOP
3 200 Skr -
Change Control Management SOP
3 000 Skr -
Quality Risk Management SOP (ICH Q9)
3 800 Skr -
Internal Audit and Self-Inspection Programme SOP
3 200 Skr -
Management Review of the Pharmaceutical Quality System SOP
2 800 Skr -
Data Integrity and ALCOA+ Governance SOP
4 000 Skr -
Supplier Qualification and Oversight SOP
4 500 Skr -
Complete Quality Management System Documentation Package (Draft Framework)
38 500 Skr -
Responsible Person (RP) Roles and Responsibilities SOP
2 800 Skr -
Cold Chain and Temperature Control Management SOP
4 000 Skr -
Receipt, Quarantine, and Release of Medicinal Products SOP
2 600 Skr -
Storage and Stock Control of Medicinal Products SOP
2 800 Skr -
Picking, Packing, and Dispatch of Medicinal Products (EU GDP) SOP
2 600 Skr -
Transport Qualification and Shipping Oversight SOP
3 800 Skr -
Temperature Mapping of Storage and Distribution Areas, Protocol and Report
5 000 Skr -
Returns, Recalls, and Falsified Medicines Handling SOP
3 200 Skr -
Outsourced Activities and Contractual Oversight SOP
3 000 Skr -
Training – Wholesale Distribution Authorisation (WDA) Responsibilities and Oversight
2 000 Skr -
Training – Good Distribution Practice (GDP) Operational Management
2 000 Skr -
Executed Batch Record (EBR) Documentation Framework Template
3 200 Skr -
Line Clearance and Batch Reconciliation SOP
2 800 Skr -
Cleaning and Sanitisation of Manufacturing Areas and Equipment SOP
3 000 Skr -
Preventive Maintenance and Calibration of Equipment and Instruments SOP
3 200 Skr -
Environmental Monitoring of Controlled Areas SOP
3 800 Skr -
Sampling of Raw Materials, Packaging Materials, and Finished Products SOP
2 800 Skr -
Out-of-Specification (OOS) and Out-of-Trend (OOT) Investigation Principles Training
4 000 Skr -
Training – Manufacturing Authorisation (MIA) Responsibilities and Oversight
2 000 Skr -
User Requirements Specification (URS) Framework Template
2 500 Skr -
Design Qualification (DQ) Framework Template
3 000 Skr -
Installation, Operational, and Performance Qualification (IQ/OQ/PQ) Protocols and Reports for Equipment (Template pack)
6 000 Skr -
Process Validation Protocol and Report (Stage 2 – Process Performance Qualification, PPQ) Template
5 000 Skr -
Cleaning Validation Protocol and Report Template
4 800 Skr -
Utilities Qualification Protocols (HVAC, PW/WFI, Compressed Air) Template
5 200 Skr -
GMP – SOP – Computerised System Validation and Assurance (CSV / CSA) Governance SOP
5 500 Skr -
Temperature Mapping Protocols for Storage and Transport Units Template
4 000 Skr -
Analytical Method Validation Protocol and Report Template (EU GMP / ICH Q2)
4 200 Skr -
Specifications for Active Substances, Drug Products, and Excipients Template
2 800 Skr -
Stability Study Protocol and Report Template
4 000 Skr -
Reference Standards and Sample Management SOP
2 800 Skr -
Trending and Control Charting Workbook
2 500 Skr -
Technology Transfer Plan (Sending and Receiving Sites)
4 000 Skr -
Comparability Protocol Template
3 000 Skr -
Regulatory Commitments and Variations Log
2 000 Skr -
Signal Management SOP
4 200 Skr -
Safety Data Exchange Agreements (SDEAs) Checklist
2 400 Skr -
GMP Fundamentals Overview Training (EU GMP and 21 CFR 210/211 Comparison)
2 000 Skr -
Data Integrity and ALCOA+ Principles Training
2 000 Skr -
Deviation and CAPA Best Practices Training
2 000 Skr -
Qualification and Validation Essentials Training (EU GMP Annex 15)
2 000 Skr -
EU GDP Audit Checklist
1 400 Skr -
EU GMP Audit checklist
1 400 Skr -
Responsible Person Daily and Weekly Activities Checklist
900 Skr -
Regulatory Dossier Due Diligence checklist.
1 600 Skr -
IRP Applications Review Checklist
1 200 Skr -
Falsified Medicines Directive (EU FMD) Audit Checklist
1 200 Skr -
Deviation, CAPA, and Change Control Forms
1 200 Skr -
Training Records and Competency Matrix Records
1 000 Skr -
Supplier Qualification Questionnaire
1 400 Skr -
Goods-in Inspection and Transport Damage Form
900 Skr -
Temperature Excursion Investigation and Stability Impact Assessment Forms
1 200 Skr -
Equipment Cleaning, Use, Calibration, and Maintenance logbooks
1 400 Skr -
Stability Pull Schedule and Sample Inventory Tracker
1 000 Skr -
Validation Traceability Matrix
1 200 Skr -
Risk assessment workbook (FMEA)
1 300 Skr -
Sale!
Starter QMS Compliance Bundle
Original price was: 12 200 Skr.8 900 SkrCurrent price is: 8 900 Skr. -
Sale!
GDP Operations Excellence Bundle
Original price was: 15 800 Skr.11 900 SkrCurrent price is: 11 900 Skr. -
Sale!
Validation & CSV Master Bundle
Original price was: 22 500 Skr.17 300 SkrCurrent price is: 17 300 Skr. -
Sale!
QC & Analytical Compliance Bundle
Original price was: 17 300 Skr.12 900 SkrCurrent price is: 12 900 Skr. -
Sale!
Pharma Training Mega Pack
Original price was: 10 000 Skr.7 500 SkrCurrent price is: 7 500 Skr. -
Sale!
Full Digital Pharma Compliance Catalogue
Original price was: 235 300 Skr.180 000 SkrCurrent price is: 180 000 Skr. -
GDP Fundamentals (EU GDP) Training
2 000 Skr -
Non-Disclosure Agreement (NDA)
500 Skr