STANDARD OPERATING PROCEDURE
Title: Global Literature Search and Review
Effective Date: 29-Dec-2021
Review Date: 29-Dec-2023 Number: LUOXIN/PHC-LIT-SOP- Version: 02
-002
Applicability: Pharmconsul
Process Owner: Quality Assurance
APPROVALS
Prepared by: JagadeeshBabuJoga 20-Dec-2021
Pharmacovigilance Manager Date
Checked by: 21-Dec-2021
N.V.Bhavya Sri
QA Co-Ordinator Date
Swamy Jinugu
Approved by: 21-Dec-2021
Quality Head Date
This SOP is the confidential property. Any unauthorised distribution or copying of
the SOP is strictly prohibited.
PHC-QA-SOP-001-01 Page 1 of 9
STANDARD OPERATING PROCEDURE
Title: Global Literature Search and Review
Effective Date: 29-Dec-2021
Review Date: 29-Dec-2023 Number: LUOXIN/PHC-LIT-SOP- Version: 02
-002
1 Purpose:
ANDA Holders are responsible for screening global scientific literature including for
adverse events which are associated with the use of active substances contained in
products for which they hold a Marketing Authorization.
The requirements for literature reviewing and case reporting are described in 21 CFR
314.80. According to the FDA Pharmacovigilance legislation:
The Medical Literature searching/reviewing also needs to be conducted for the purpose of
ICSRs and periodic Adverse Drug Experience Reports (PADER) and the ongoing safety
reviews.
2 Scope:
The scope of this SOP is to describe a procedure for screening, reviewing, assessing and
documenting searches of published medical literature for adverse events. This is required
for all the molecules of ANDA Holder that fall under Generics Pharmacovigilance system
(registered and under process of registration).
3. Responsibility:
3.1 Data entry: Responsible for assessing if the case received is of article or case report.
Verifying the country. Performing Primary screening, maintaining trackers.
3.2 QC: Responsible for reviewing the initial assessment and correct the case validity if any
missing.
PHC-QA-SOP-001-01 Page 2 of 9
STANDARD OPERATING PROCEDURE
Title: Global Literature Search and Review
Effective Date: 29-Dec-2021
Review Date: 29-Dec-2023 Number: LUOXIN/PHC-LIT-SOP- Version: 02
-002
3.3 MR: Responsible for verifying the case validity, reportability and maintaining the
respective trackers.
4. Procedure:
4.1 Master license list:
4.1.1 The master license list for LUOXIN products been maintained by LUOXIN
Regulatory Affairs department. This list shall be updated whenever there are new
ANDA were entered into Market from the company.
4.1.2 The LUOXIN has to inform the Pharmconsul promptly whenever an application
for a new Marketing Authorization is submitted/ approval / cancellation of MA
within 3 Business days.
4.2 Maintenance of the medical literature search list
4.2.1 The Medical literature search list is maintained by designated pharmacovigilance
personnel with review performed on a regular basis, quality check shall be
conducted with every update of the product list as part of the monthly compliance
monitoring of designated PV activities.
4.2.2 A template for the medical literature search list is presented in Form 1.
4.2.3 Any new/additional active substances shall be added to the medical literature
search list following notification after through cross reference from the master
license list.
4.2.4 Any active substance for which there is no longer any MA held by one of the
PHC-QA-SOP-001-01 Page 3 of 9
STANDARD OPERATING PROCEDURE
Title: Global Literature Search and Review
Effective Date: 29-Dec-2021
Review Date: 29-Dec-2023 Number: LUOXIN/PHC-LIT-SOP- Version: 02
-002
ANDA Holder shall, in due course, shall be removed from the Literature search.
The expiry dates of any remaining batches on the market for the product
concerned are to be taken into consideration.
4.3 Search in Pubmed and Springer Nature:
4.3.1 Global literature is conducted in terms of Weekly Medical literature searching.
4.3.2 The service provider or team shall perform weekly searches of the designated
medical databases ( Pubmed and Springer Nature). Search terms include the
recommended International Non-proprietary Name (rINN) and synonyms for
each active substance contained in products for which the companies hold a
Marketing Authorization. Eg: Paracetamol / Acetaminophen.
4.3.3 The search from the PubMED is saved as alerts. Alerts are set to run automatically
once every week on Tuesday. Search from Springer will be done manually.
4.3.4 If, alerts are not generated from PubMED, manual search to be done by Literature team
on Tuesday. If Tuesday is holiday. Then search to be done on next business day.
4.3.5 The search shall be made based on the generic name (as well as brand name if
provided) ("Substance name"[MeSH Terms] OR "Substance name "[All Fields]) AND
("custom date range”).
4.3.6 Unless medically relevant, the search shall not be based on particular salt or specific
compound for an active ingredient.
4.3.7 The search shall be broadened or narrowed as per Client requirement with prior
agreement.
4.3.8 Follow-up must be done with respective Authors if suspicious about the validity
4.3.9 Search details to be recorded in Form 1.
4.3.10 Articles which do not have minimum safety information are considered as invalid or
PHC-QA-SOP-001-01 Page 4 of 9
STANDARD OPERATING PROCEDURE
Title: Global Literature Search and Review
Effective Date: 29-Dec-2021
Review Date: 29-Dec-2023 Number: LUOXIN/PHC-LIT-SOP- Version: 02
-002
incomplete articles.
4.4 Processing of weekly literature search results
4.4.1 Weekly alerts received from the PubMed are to be saved under receipt (week) +
date (DDMMYYYY) under the active substance named folder.
4.4.2 Search results from Springer Nature will be assessed and archived in the similar way.
4.4.3 Screening/DE step: The alerts of PubMED and results of Springer nature will be
screened by trained team member to determine:
4.4.3.1 If it is a molecule from the updated approved products list.
4.4.3.2 EMEA website will be referred for IME/DME List
4.4.3.3 Whether it is an Individual case safety report or an article.
4.4.3.4 Country of origin of case/article.
4.4.3.5 Applicant’s country of license.
4.4.3.6 DE comments as “Article was assessed for the validity. Identified as Valid/Non
valid”
4.4.3.7 QC Comments as “ No comments” if DE assessment was correct.
as “Wrong assessment” if DE assessment is not accurate.
Respective errors of assessment will be corrected and recorded in form 2.
4.4.2.8 For selecting a literature article as a valid case / ICSR, the literature should have four
minimum criteria for case creation. At least, one identifiable reporter, one identifiable
patient, one suspected adverse reaction and one suspected medicinal product.
Selection of Literature article as valid cases for ICSRs shall be based on the above
points and the possibility that the event may be attributed with use of the suspected
medicinal product. This should be judged while reviewing the article.
Medical Review Screening/ MR Step: (to be conducted by a trained medic. Comments shall
PHC-QA-SOP-001-01 Page 5 of 9
STANDARD OPERATING PROCEDURE
Title: Global Literature Search and Review
Effective Date: 29-Dec-2021
Review Date: 29-Dec-2023 Number: LUOXIN/PHC-LIT-SOP- Version: 02
-002
include whether they are:
Identified as an ICSR as per the Marketed list of ANDA Holder
Treated as an adverse event/reaction/beneficial effect
Excluded if not relevant
The relevant publications shall also be screen for the following reports apart from standard
adverse events:
Paediatric use
Compassionate supply and named patient use
Lack of effect
Asymptomatic overdose, misuse and abuse cases
Medication errors
Pregnancy cases (exposure during pregnancy with no harmful effects)
Important non-clinical safety results
Occupational exposure
Special population (Hepatic, Renal failure conditions etc.)
4.4.4 The Literature team should inform any adverse events to the respective case
processing resources within 4 Calendar days.
4.4.5 Reports on relevant literature reviews that do not relate to specific adverse events
are highlighted for review – for PADER.
4.5 Recording weekly medical literature search results
4.5.1 Every week the literature Search List (form 1) is to be updated to record the number of
reports received for the individual drug in that week.
4.5.2 Electronic copies of all reviewed and marked Literature search copies will be stored
electronically.
PHC-QA-SOP-001-01 Page 6 of 9
STANDARD OPERATING PROCEDURE
Title: Global Literature Search and Review
Effective Date: 29-Dec-2021
Review Date: 29-Dec-2023 Number: LUOXIN/PHC-LIT-SOP- Version: 02
-002
4.5.3 Full text articles are to be ordered if the literature case needs to be reported or if further
evaluation is required in order to assess completely for validity. PDF copies must be
stored in company dive.
4.5.4 During literature review, if any article requires full text for complete assessment of
the report, then the concerned designee shall search in Google or any other websites
for procurement of the full text.
If any Full texts are with paying option, then Pharmconsul shall purchase paid articles
upon approval by Client. In this scenario, Pharmconsul will send a notification mailer
to LUOXIN within 3 business days from the search date for getting the Full text.
4.5.5 Ordering translation: When the publication is not in English, a translation may be
necessary. Translation of any literature articles shall be obtained from Client. It is not
always necessary to translate the full article.
The translation may be limited to the abstract or pertinent sections of the article as
long as it fulfills all the necessary case information. If the case is determined to be
valid, full translation will be required.
In this kind of scenarios, Pharmconsul will approach LUOXIN with e-mail
notification for translated document within 3 business days from the search date.
4.5.6 The cost incurred for procuring the full text article and translation of article in
foreign language shall be borne by LUOXIN.
4.6 Reporting of Literature Cases
4.6.1 Provided the literature case has been correctly identified as per the section above,
PHC-QA-SOP-001-01 Page 7 of 9
STANDARD OPERATING PROCEDURE
Title: Global Literature Search and Review
Effective Date: 29-Dec-2021
Review Date: 29-Dec-2023 Number: LUOXIN/PHC-LIT-SOP- Version: 02
-002
cases must be reported in line with protocols listed in the current version.
4.6.2 Day 0 in literature search is the day when initial search was conducted. The same
was applicable for FUs also.
4.6.3 Literature Reportable case tracker (form 2) must be filled with results of search.
5 Acronyms:
5.1 ANDA-Abbreviated new drug application.
5.2 SRP- Safety Reporting Portal.
5.3 MR-Medical Review.
5.4 WHO- World health organization.
5.5 QC - Quality Check
6. Appendix:
6.1 Form 1 – Literature search List
6.2 Form 2 – Literature Reportable case Tracker
7. References:
USFDA Guidelines.
8. Version Control:
Supersede Change Reason for revision
Version No. Control No.
Version-01 CC/21/005 1. Title of SOP has been modified from Global and
Local Literature Search and Review to Global
Literature Search and Review.
PHC-QA-SOP-001-01 Page 8 of 9
STANDARD OPERATING PROCEDURE
Title: Global Literature Search and Review
Effective Date: 29-Dec-2021
Review Date: 29-Dec-2023 Number: LUOXIN/PHC-LIT-SOP- Version: 02
-002
2. 4.1.1 has been modified as The master license list
for LUOXIN products been maintained by
LUOXIN Regulatory Affairs department. This list
shall be updated whenever there are new ANDA
were entered into Market from the company.
3. 4.4.2. EMEA website will be referred for
IME/DME List included.
4. DE and QC comments were modified as below
DE comments as “Article was assessed for the
validity. Identified as Valid/Non valid”
5. 4.3, 4.4 sections has been modified with addition
of Springer nature search.
QC Comments as “ No comments” if DE assessment
was correct.
QC Comments as “Wrong assessment” if DE assessment
is not accurate. Respective errors of assessment will be
corrected and recorded in form 2.
END OF THE DOCUMENT
PHC-QA-SOP-001-01 Page 9 of 9
