1.0 OBJECTIVE:
1.1. To define the procedure for performing local and global literature screening to identify published information related to Adverse Events (AE), Adverse Drug Reactions (ADR), product safety issues, signals, and risk-related information.

1.2. To ensure compliance with World Health Organization (WHO) and European Union Good Pharmacovigilance Practices (EU-GVP) requirements.

1.3. To ensure all literature-based safety reports are identified, assessed, and processed as Individual Case Safety Reports (ICSR) or safety signals as needed.

2.0 SCOPE:
2.1. Applies to all marketed medicinal products for which the company is the Marketing Authorization Holder (MAH) or is responsible for Pharmacovigilance (PV).

2.2. Covers global scientific databases, local country journals, news sources, and medical publications.

2.3. Applies to PV, Regulatory Affairs (RA), and contracted vendors performing literature searches, if any.

3.0 RESPONSIBILITIES:
3.1. Pharmacovigilance (PV) Department:
3.1.1. Develops and maintains the literature search strategy.
3.1.2. Performs or oversees global and local searches.
3.1.3. Screens articles for reportable ICSRs and signals.
3.1.4. Ensures timely processing and documentation of findings.
3.1.5. Maintain case audit trail and documentation.

3.2. Regulatory Affairs (RA):
3.2.1. Provides country-specific requirements for local literature.
3.2.2. Shares newly added local journals, bulletins, or authority updates.

3.3. Quality Assurance (QA):
3.3.1. Ensures adequacy and compliance of the literature process.
3.3.2. Reviews significant safety findings from literature.

4.0 DEFINATIONS:
4.1. Literature Screening: Systematic review of published scientific and medical information to detect safety-related information.

4.2. Local Literature: Publications within the specific country where the product is marketed (local journals, health bulletins, regional newspapers).

4.3. Global Literature: International scientific sources such as PubMed, Embase, Scopus, Medline, and indexed journals.

4.4. ICSR: Individual Case Safety Report identified from literature containing reportable AE/ADR information.

4.5. Signal: Reported information suggesting a new or changing risk related to the product.

4.6. Search Term Strategy: Keywords related to product, ingredient, formulation, class, and safety events.

5.0 PROCEDURE:
5.1 Establishing Literature Sources:
5.1.1. Following Global Literature Source shall use for Literature screening or researches.
5.1.1.1. PubMed
5.1.1.2. Embase
5.1.1.3. Scopus
5.1.1.4. Medline
5.1.1.5. Google Scholar
5.1.1.6. WHO database (if applicable)
5.1.1.7. Other global indexed journals

5.1.2. Following Local Literature Source shall use for Literature screening or researches.
5.1.2.1. Local medical journals
5.1.2.2. Pharmacy journals
5.1.2.3. National health bulletins
5.1.2.4. Drug safety newsletters
5.1.2.5. Country-specific health ministry publications
5.1.2.6. Local newspapers (if required by authority)

5.1.3. If a vendor performs literature screening, the responsibilities must be documented in the Safety Data Exchange Agreement (SDEA).

5.1.4. Global literature screening shall perform Weekly (minimum requirement) and Local literature screening shall perform Monthly.

5.2 Search Strategy Development:
5.2.1 Include all product names, active pharmaceutical ingredients, salt forms, brand names, class names, and known ADR terms.

5.2.2 Example search terms:
5.2.2.1 “Product X” AND “adverse reaction”
5.2.2.2 “Active ingredient name” AND “safety”
5.2.2.3 “Product X” AND “toxicity”

5.2.3 Search strategies must be documented and approved by PV Lead/QPPV.

5.3 Article Screening Process
5.3.1 Pharmacovigilance dept shall screen all retrieved results for relevance.

5.3.2 Articles shall be categorized into:
5.3.2.1 ICSR-positive (contains reportable patient case)
5.3.2.2 Signal-relevant
5.3.2.3 Safety-relevant but non-case
5.3.2.4 Not relevant

5.3.3 For each relevant article, retain:
5.3.3.1 Full citation
5.3.3.2 Search date
5.3.3.3 Article copy or screen capture
5.3.3.4 Reason for categorization

5.4 Identification of ICSRs from Literature:
5.4.1 An article qualifies as an ICSR if:
5.4.1.1 Identifiable patient
5.4.1.2 Identifiable reporter (journal author)
5.4.1.3 Suspect product
5.4.1.4 Event description presents

5.4.2 If criteria met = create ICSR/YY/NNN case number.
5.4.3 Extract all required data verbatim.

5.5 Processing Literature ICSRs
5.5.1 Literature ICSRs shall follow the same workflow as any ICSR:
5.5.1.1 Data entry into safety database
5.5.1.2 MedDRA coding
5.5.1.3 Causality assessment
5.5.1.4 Case validation
5.5.1.5 Regulatory reporting

5.5.2 Regulatory timelines:
5.5.2.1 Serious literature cases shall Report within 24–48 hours or (country-specific).
5.5.2.2 Non-serious literature cases shall Report within 90 days.

5.6 Signal Identification:
5.6.1 Following articles shall suggest signal identification:
5.6.1.1 new adverse reaction
5.6.1.2 unexpected severity
5.6.1.3 lack of efficacy
5.6.1.4 off-label use
5.6.1.5 product misuse
5.6.1.6 medication error should be categorized as signal-relevant.

5.6.2 QPPV shall evaluate signal relevance for further assessment.

5.7 Documentation Requirements:
5.7.1 Maintain a Literature Screening Log, including:
5.7.1.1 Date searched
5.7.1.2 Database/source
5.7.1.3 Search terms
5.7.1.4 Number of hits
5.7.1.5 Categorization
5.7.1.6 ICSRs identified
5.7.1.7 Signal articles
5.7.1.8 Reviewer name/signature

5.7.2 Retain copies/screenshots of all search results and store all documents in controlled environment.

5.8 Quality Review:
5.8.1 Monthly review shall perform for literature screening completeness.

5.8.2 Annual review shall perform for search strategy effectiveness and CAPA shall be raised for missed ICSRs or poor documentation.

5.9 Training:
5.9.1 All PV personnel must be trained on literature screening SOP. Training must be documented.

5.9.2 The Literature screening data shall be retained for 5 years.

5.10 Deviations:
5.10.1 Deviations from this SOP shall be recorded following deviation SOP.

5.10.2 QPPV shall be notified for any delayed screening or missed ICSR.

6.0 REFERENCES:
6.2 WHO Technical Report Series (TRS) – PV guidance

6.3 EU Good Pharmacovigilance Practices (GVP)

6.4 Company QMS SOPs (Document Control, Training, Audit, Risk Management, Deviation & CAPA)

7.0 RECORDS:
Sr No. Title Document No.
1 Literature screening log F/PV006/001 – 00
2 Literature Article Review Form F/PV006/002 – 00
3 Monthly Summary Report F/PV006/003 – 00

8.0 REVISION HISTORY.
Amendment Date: Update Summary Version No.
NA New SOP 01