| # | SOP No. | SOP Title | Category | Enquiry | Pay Now |
|---|---|---|---|---|---|
| 1 | CA001 | Training Personnel | Clinical Affairs | Enquiry | Pay Now |
| 2 | CA002 | Responsibilities of Research Team | Clinical Affairs | Enquiry | Pay Now |
| 3 | CA003 | Conduct of Clinical Study | Clinical Affairs | Enquiry | Pay Now |
| 4 | CA004 | Document Control | Clinical Affairs | Enquiry | Pay Now |
| 5 | CA005 | Regulatory Documentation (regulatory binder) | Clinical Affairs | Enquiry | Pay Now |
| 6 | CA006 | Privacy and Confidentiality | Clinical Affairs | Enquiry | Pay Now |
| 7 | CA007 | IRB Submission | Clinical Affairs | Enquiry | Pay Now |
| 8 | CA008 | Adverse Event Reporting | Clinical Affairs | Enquiry | Pay Now |
| 9 | CA009 | Conflicts of Interest | Clinical Affairs | Enquiry | Pay Now |
| 10 | CA010 | Study Feasibility | Clinical Affairs | Enquiry | Pay Now |
| 11 | CA011 | Site Qualification visit | Clinical Affairs | Enquiry | Pay Now |
| 12 | CA012 | Site Initiation visit | Clinical Affairs | Enquiry | Pay Now |
| 13 | CA013 | Communication Practices | Clinical Affairs | Enquiry | Pay Now |
| 14 | CA014 | Investigational Product Accountability | Clinical Affairs | Enquiry | Pay Now |
| 15 | CA015 | Randomization and Blinding | Clinical Affairs | Enquiry | Pay Now |
| 16 | CA016 | Venipuncture | Clinical Affairs | Enquiry | Pay Now |
| 17 | CA017 | Specimens Collection and Management | Clinical Affairs | Enquiry | Pay Now |
| 18 | CA018 | Preparing Injectable Medications | Clinical Affairs | Enquiry | Pay Now |
| 19 | CA019 | Site Monitoring Visit | Clinical Affairs | Enquiry | Pay Now |
| 20 | CA020 | Site Closeout Visit | Clinical Affairs | Enquiry | Pay Now |
| 21 | CA021 | Protocol Compliance | Clinical Affairs | Enquiry | Pay Now |
| 22 | CA022 | Subject Recruitment | Clinical Affairs | Enquiry | Pay Now |
| 23 | CA023 | Informed Consent | Clinical Affairs | Enquiry | Pay Now |
| 24 | CA024 | Eligibility and Enrollment | Clinical Affairs | Enquiry | Pay Now |
| 25 | CA025 | Protecting Confidentiality of Study Subjects | Clinical Affairs | Enquiry | Pay Now |
| 26 | CA026 | Study Visits | Clinical Affairs | Enquiry | Pay Now |
| 27 | CA027 | Payments to Subjects | Clinical Affairs | Enquiry | Pay Now |
| 28 | CA028 | Case Report Forms | Clinical Affairs | Enquiry | Pay Now |
| 29 | CA029 | Source Documentation | Clinical Affairs | Enquiry | Pay Now |
| 30 | CA030 | Electronic Records | Clinical Affairs | Enquiry | Pay Now |
| 31 | CA031 | Archiving Study Records | Clinical Affairs | Enquiry | Pay Now |
| 32 | CA032 | Printing and Certifying Medical Records | Clinical Affairs | Enquiry | Pay Now |
| 33 | CA033 | Quality Control | Clinical Affairs | Enquiry | Pay Now |
| 34 | CA034 | FDA Audits | Clinical Affairs | Enquiry | Pay Now |
| 35 | CA035 | Corrective and Preventative Action Plan | Clinical Affairs | Enquiry | Pay Now |
| 36 | CA036 | Equipment Maintenance and Calibration | Clinical Affairs | Enquiry | Pay Now |
| 37 | CA037 | Temperature Monitoring | Clinical Affairs | Enquiry | Pay Now |
| 38 | PV001 | Development & Maintenance of PSMF | Pharmacovigilance | Enquiry | Pay Now |
| 39 | PV002 | Roles & Responsibilities of the QPPV and Deputy QPPV | Pharmacovigilance | Enquiry | Pay Now |
| 40 | PV003 | Pharmacovigilance Training | Pharmacovigilance | Enquiry | Pay Now |
| 41 | PV004 | Storage & Archiving of PV Documents | Pharmacovigilance | Enquiry | Pay Now |
| 42 | PV005 | Audits and inspections of PV System | Pharmacovigilance | Enquiry | Pay Now |
| 43 | PV006 | Management of Corrective Actions & Preventive Actions (CAPAs) | Pharmacovigilance | Enquiry | Pay Now |
| 44 | PV007 | Preparation of Safety Data Exchange Agreement (SDEA) | Pharmacovigilance | Enquiry | Pay Now |
| 45 | PV008 | Management of Product Quality Complaints (PQCs) | Pharmacovigilance | Enquiry | Pay Now |
| 46 | PV009 | Management of Literature Search Activities | Pharmacovigilance | Enquiry | Pay Now |
| 47 | PV010 | Management of Individual Case Safety Reports (ICSRs) | Pharmacovigilance | Enquiry | Pay Now |
| 48 | PV011 | Case Processing using 24-7 PV Assured Safety Database | Pharmacovigilance | Enquiry | Pay Now |
| 49 | PV012 | Handling of Urgent Safety Restrictions & Safety Variations | Pharmacovigilance | Enquiry | Pay Now |
| 50 | PV013 | Management of Queries from Health Authorities | Pharmacovigilance | Enquiry | Pay Now |
| 51 | PV014 | Management of Company Core Data Sheets (CCDS), and Local Labels including SmPCs & PI | Pharmacovigilance | Enquiry | Pay Now |
| 52 | PV015 | Management of Periodic Safety Update Reports (PSURs) | Pharmacovigilance | Enquiry | Pay Now |
| 53 | PV016 | Management of Signal Detection Activities | Pharmacovigilance | Enquiry | Pay Now |
| 54 | PV017 | Management of Risk Management Plans (RMPs) | Pharmacovigilance | Enquiry | Pay Now |
| 55 | PV018 | Medical Device Vigilance procedure | Pharmacovigilance | Enquiry | Pay Now |
| 56 | PV019 | MIR Case Processing using 24-7 PV Assured Safety Database | Pharmacovigilance | Enquiry | Pay Now |
| 57 | PV020 | Reporting manufacturing incident report and MIR additional information form to Authority | Pharmacovigilance | Enquiry | Pay Now |
| 58 | PV021 | Post Marketing Safety Studies | Pharmacovigilance | Enquiry | Pay Now |
| 59 | PV022 | Handling Medical Informaiton Query | Pharmacovigilance | Enquiry | Pay Now |
| 60 | PV023 | BCP For Pharmacovigilance Department | Pharmacovigilance | Enquiry | Pay Now |
| 61 | PV024 | Preparation of SmPC | Pharmacovigilance | Enquiry | Pay Now |
| 62 | PV025 | Addendum of clinical overview | Pharmacovigilance | Enquiry | Pay Now |
| 63 | PV026 | Documents control procedures | Pharmacovigilance | Enquiry | Pay Now |
| 64 | PV027 | Fulfillment of PASS PAES obligations procedures | Pharmacovigilance | Enquiry | Pay Now |
| 65 | PV028 | Inspection readiness procedures | Pharmacovigilance | Enquiry | Pay Now |
| 66 | PV029 | Interaction of Pharmacovigilance with other departments procedures | Pharmacovigilance | Enquiry | Pay Now |
| 67 | PV030 | Monitoring performance of PV system procedure | Pharmacovigilance | Enquiry | Pay Now |
| 68 | PV031 | Reporting to national medicines authority and duplication detection procedure | Pharmacovigilance | Enquiry | Pay Now |
| 69 | PV032 | Safety communication procedures | Pharmacovigilance | Enquiry | Pay Now |
| 70 | PV033 | Decision Tree for Adverse event reporting | Pharmacovigilance | Enquiry | Pay Now |
| 71 | PV034 | Guidlines for processing medical device cases | Pharmacovigilance | Enquiry | Pay Now |
| 72 | PV035 | Lifecycle Safety-Medical Review of Adverse Events | Pharmacovigilance | Enquiry | Pay Now |
| 73 | PV036 | Preparation and Review of EU RMP | Pharmacovigilance | Enquiry | Pay Now |
| 74 | PV037 | Preparation of Device Specific guidance documents | Pharmacovigilance | Enquiry | Pay Now |
| 75 | PV038 | Reporting MIR To Authority | Pharmacovigilance | Enquiry | Pay Now |
| 76 | PV039 | RMP template | Pharmacovigilance | Enquiry | Pay Now |
| 77 | PV040 | Spontaneous Reporting of Adverse Device Reactions | Pharmacovigilance | Enquiry | Pay Now |
| 78 | PV041 | Reporting PSR and Trend report | Pharmacovigilance | Enquiry | Pay Now |
| 79 | PV042 | Case Management (Manual) | Pharmacovigilance | Enquiry | Pay Now |
| 80 | PV043 | Spontaneous Reporting of Adverse Device Reactions | Pharmacovigilance | Enquiry | Pay Now |
| 81 | PV044 | QA, audit & inspection activities | Pharmacovigilance | Enquiry | Pay Now |
| 82 | PV045 | Lifecycle Safety-Medical Review of Adverse Events | Pharmacovigilance | Enquiry | Pay Now |
| 83 | QA001 | SOP on SOP | Quality Assurance | Enquiry | Pay Now |
| 84 | QA002 | Quality Management Review | Quality Assurance | Enquiry | Pay Now |
| 85 | QA003 | Product Quality Review | Quality Assurance | Enquiry | Pay Now |
| 86 | QA004 | Preparation of Master Formula Record (MFR), Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR) | Quality Assurance | Enquiry | Pay Now |
| 87 | QA005 | Issuance and retrieval of BMR and BPR | Quality Assurance | Enquiry | Pay Now |
| 88 | QA006 | Document Numbering System | Quality Assurance | Enquiry | Pay Now |
| 89 | QA007 | Document & Data Control | Quality Assurance | Enquiry | Pay Now |
| 90 | QA008 | Preparation, review, approval and control of Standard Testing Procedure | Quality Assurance | Enquiry | Pay Now |
| 91 | QA009 | Preparation, review, approval and control of Analytical Work Sheets | Quality Assurance | Enquiry | Pay Now |
| 92 | QA010 | Review of BMR and BPR | Quality Assurance | Enquiry | Pay Now |
| 93 | QA011 | Good Documentation Practices | Quality Assurance | Enquiry | Pay Now |
| 94 | QA012 | Specimen signature | Quality Assurance | Enquiry | Pay Now |
| 95 | QA013 | Preparation, Approval and Execution of Validation Protocols and Reports | Quality Assurance | Enquiry | Pay Now |
| 96 | QA014 | VMP preparation, approval & review | Quality Assurance | Enquiry | Pay Now |
| 97 | QA015 | Change Control Management | Quality Assurance | Enquiry | Pay Now |
| 98 | QA016 | Deviation Management | Quality Assurance | Enquiry | Pay Now |
| 99 | QA017 | OOS (Out of Specification) | Quality Assurance | Enquiry | Pay Now |
| 100 | QA018 | OOT (Out of Trending) | Quality Assurance | Enquiry | Pay Now |
| 101 | QA019 | RCA (Root Cause Analysis) | Quality Assurance | Enquiry | Pay Now |
| 102 | QA020 | FMEA (Failure mode & Effective Analysis) | Quality Assurance | Enquiry | Pay Now |
| 103 | QA021 | CAPA | Quality Assurance | Enquiry | Pay Now |
| 104 | QA022 | Handling and Investigations of non-conformances | Quality Assurance | Enquiry | Pay Now |
| 105 | QA023 | Self Inspection | Quality Assurance | Enquiry | Pay Now |
| 106 | QA024 | In-process for all dosage forms | Quality Assurance | Enquiry | Pay Now |
| 107 | QA025 | Line Clearance | Quality Assurance | Enquiry | Pay Now |
| 108 | QA026 | Status Labeling | Quality Assurance | Enquiry | Pay Now |
| 109 | QA027 | Final Inspection & Release of Finished goods | Quality Assurance | Enquiry | Pay Now |
| 110 | QA028 | Receiving of new equipment in facility and coding | Quality Assurance | Enquiry | Pay Now |
| 111 | QA029 | Vendor Qualification | Quality Assurance | Enquiry | Pay Now |
| 112 | QA030 | Product Recall | Quality Assurance | Enquiry | Pay Now |
| 113 | QA031 | Market complaints | Quality Assurance | Enquiry | Pay Now |
| 114 | QA032 | Control of Pricelist | Quality Assurance | Enquiry | Pay Now |
| 115 | QA033 | Reprocessing & Reworking | Quality Assurance | Enquiry | Pay Now |
| 116 | QA034 | Technology Transfer | Quality Assurance | Enquiry | Pay Now |
| 117 | QA035 | Prevention of mix-up and cross contamination | Quality Assurance | Enquiry | Pay Now |
| 118 | QA036 | Destruction policy | Quality Assurance | Enquiry | Pay Now |
| 119 | QA037 | Training of personnel | Quality Assurance | Enquiry | Pay Now |
| 120 | QA038 | Handling of returned goods | Quality Assurance | Enquiry | Pay Now |
| 121 | QA039 | Incident Reporting | Quality Assurance | Enquiry | Pay Now |
| 122 | QA040 | Disinfectant Usage Policy | Quality Assurance | Enquiry | Pay Now |
| 123 | QA041 | Checking of Overprinting material | Quality Assurance | Enquiry | Pay Now |
| 124 | QA042 | Environmental Monitoring | Quality Assurance | Enquiry | Pay Now |
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