# | 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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