PREreview of Ensuring Quality Medicine is not a Single Event Rather Combine Effects of a Pharmaceutical Company

Formal Peer Review Report

Manuscript Title: "Ensuring Quality Medicine is not a Single Event Rather Combine Effects of a Pharmaceutical Company" Author: Rashed Ahmed, North South University Platform: Preprints.org (DOI: 10.20944/preprints202407.1336.v2) Review Date: February 2026 Reviewer Status: Independent Academic Reviewer

1. Summary Assessment

This manuscript addresses the broadly acknowledged principle that pharmaceutical quality assurance is a continuous, multi-departmental endeavor rather than a discrete, singular activity. The topic itself is legitimate and professionally relevant; however, the manuscript as submitted does not meet the scholarly standards expected of a peer-reviewed publication in pharmaceutical sciences, regulatory science, or quality management.

The work reads primarily as a descriptive, textbook-style exposition of established concepts—GMP, cGMP, QC, QA, GLP, and IPQC—without generating new knowledge, testing hypotheses, analyzing primary or secondary data, or advancing a novel theoretical framework. The research methodology section, which constitutes a disproportionately large portion of the manuscript, describes generic online research and literature review procedures rather than a defined, reproducible research design. The stated objectives are broad and aspirational but are not operationalized or tested. The "Analytical Discussion" section largely restates the abstract and fails to critically synthesize findings against prior literature.

In its current form, the manuscript is more appropriately classified as a professional commentary or educational overview than a research article. Substantial reconceptualization—including the development of an original research question, empirical or systematic methodology, and a meaningful analytical contribution—would be required before this work could be considered for publication in a Scopus- or Web of Science-indexed journal.

2. Major Concerns

MC-1: Absence of Original Research Contribution The manuscript presents no original data, no empirical investigation, no systematic review, and no novel conceptual framework. All content describes well-established industry concepts available in regulatory guidance documents (FDA, EMA, WHO) and standard pharmaceutical sciences textbooks. The work does not advance the field in any demonstrable way.

MC-2: Methodological Incoherence The methodology section describes "online research" and "literature review" in generic, procedural terms. It does not specify inclusion/exclusion criteria, search terms used, databases queried systematically, number of sources screened versus included, or a quality appraisal framework (e.g., PRISMA for systematic reviews). This description is indistinguishable from undergraduate-level research procedures and cannot be considered a scientific methodology.

MC-3: Undefined and Undemonstrated Research Gap The manuscript does not identify a specific gap in the existing literature. The claim that quality medicine requires combined organizational effort is a principle universally acknowledged in regulatory frameworks (ICH Q10, ISO 9001, WHO Technical Report Series) and requires no further demonstration. Without a clearly articulated and evidenced research gap, the rationale for the study is absent.

MC-4: Research Objectives Lack Operationalization Six research objectives are listed; however, none are operationalized through measurable variables, analytical frameworks, or testable propositions. The manuscript provides no evidence that these objectives were systematically investigated or achieved beyond narrative description.

MC-5: Inadequate and Potentially Unreliable Reference List The reference list contains only eight citations, several of which raise significant concerns. Specifically, certain references (e.g., Bauman 2013 in "Quality Control Review," Wright 2020 in "Pharmaceutical Quality Journal") could not be independently verified and may not correspond to legitimate indexed publications. The absence of foundational regulatory documents—ICH Q7, Q8, Q9, Q10; FDA cGMP guidelines; WHO TRS documents; EMA GMP guidelines—is a critical deficiency for a manuscript on this topic.

MC-6: Self-Referential Abstract The abstract begins with the phrase "The article 'Ensuring Quality Medicine is Not a Single Event…' explores…," which is inappropriate. An abstract should summarize the content and findings of the article itself, not describe it in the third person as though reviewing another work.

MC-7: IMRaD Structure Not Followed The manuscript does not follow an Introduction-Methods-Results-Discussion structure. There is no Results section. The "Analytical Discussion" does not contain original analysis. The work conflates what would be a literature review with its findings and conclusions.

3. Minor Concerns

mn-1: The manuscript title contains a grammatical error ("Combine Effects" should read "Combined Effects"), which undermines its professional presentation.

mn-2: Terminology is occasionally inconsistent. "Quality Control" and "Quality Assurance" are used interchangeably in certain passages despite referring to distinct functions.

mn-3: The methodology section contains first-person narrative descriptions of generic research procedures that read as student-facing instructional text rather than academic methodology.

mn-4: Several typographical and grammatical errors appear throughout (e.g., "evauated theonline sources"), suggesting the manuscript was not subjected to professional language editing prior to submission.

mn-5: The keyword list includes "pharmacists," a term that is neither defined in the text nor meaningfully connected to the manuscript's content.

mn-6: The "Analytical Discussion" section is too brief (approximately one paragraph) relative to the length of the descriptive sections, and it adds no substantive analytical value.

mn-7: No figures, tables, or conceptual models are included. For a manuscript of this scope, at least a process model or framework diagram would be expected.

4. Methodology Critique

The research methodology described in this manuscript does not constitute a scientific method in any academically defensible sense. The author describes two methods: "online research" and "literature review." The description of online research spans multiple pages and reads as a general tutorial on internet-based information gathering rather than a specification of the research design employed in this study.

A legitimate scholarly methodology for this type of work would require, at minimum, one of the following approaches: (a) a systematic or scoping review with PRISMA-compliant documentation; (b) an empirical study involving primary data collection (e.g., surveys, interviews, or case studies within pharmaceutical organizations); (c) a comparative regulatory analysis using a defined analytical framework; or (d) a mixed-methods approach integrating document analysis and expert consultation.

None of these approaches are evident. The manuscript lacks specification of search strings, databases queried, date ranges applied, inclusion/exclusion criteria, number of sources identified and retained, or any quality appraisal of included literature. The work is therefore not reproducible, and its conclusions cannot be assessed for evidential validity.

5. Data Presentation Evaluation

The manuscript contains no tables, figures, data visualizations, or conceptual frameworks. For a scholarly article examining the integrated quality systems of pharmaceutical organizations, the absence of any visual representation—such as a quality management system model, a process flow diagram, or a comparative table of GMP/GLP/IPQC functions—significantly diminishes its communicative and scholarly value. Descriptive prose alone, without supporting evidence or structured representations, is insufficient for a research publication in this domain.

6. Contribution and Novelty Assessment

The manuscript's contribution to the field is, regrettably, negligible. The core thesis—that pharmaceutical quality assurance is a continuous, integrated, cross-functional process—is not novel. This principle is foundational to ICH Q10 (Pharmaceutical Quality System), ISO 9001:2015, and decades of regulatory guidance from the FDA, EMA, and WHO. It is taught at the undergraduate level in pharmacy and pharmaceutical sciences programs globally.

For this work to make a meaningful scholarly contribution, it would need to demonstrate one or more of the following: a new synthesis or meta-analysis revealing previously unidentified patterns; an empirical investigation of how these principles are applied (or not applied) across specific industry contexts or regulatory jurisdictions; a novel framework for quality integration that extends beyond existing models; or a comparative analysis identifying gaps between regulatory intent and industry practice. None of these elements are present.

The contribution is assessed as negligible in its current form.

7. Publication Suitability Scores

CriterionScore (1–10)RationaleOriginality2No novel concepts, data, or frameworks presentedMethodological Rigor1No defensible scientific methodology presentPractical Relevance4Topic is relevant; content is too generic to be actionableClarity of Writing3Significant grammatical errors; structure is inconsistentOverall Publication Readiness2Requires fundamental reconceptualization

8. Editorial Recommendation

☒ Reject — Encourage Resubmission After Fundamental Revision

The manuscript in its current form does not meet the minimum scholarly standards required for publication in a peer-reviewed journal. The absence of a novel research contribution, a reproducible methodology, original data or analysis, and an adequate and verifiable reference base preclude acceptance or revision under the current conceptual framework.

However, the topic domain is legitimate and professionally relevant. The author is encouraged to reconceptualize the work substantially—either as a systematic/scoping review conducted in accordance with PRISMA guidelines, an empirical study, or a theoretically grounded regulatory analysis—and resubmit upon completion of this reconceptualization. A resubmission that addresses the concerns outlined below would be considered.

9. Revision Roadmap

The following structured recommendations are provided to guide substantive revision:

R-1: Reconceptualize the Research Design Determine whether this work will be repositioned as (a) a systematic/scoping review, (b) an empirical study, or (c) a regulatory/policy analysis. Each requires a fundamentally different methodology. Select one and design the study accordingly.

R-2: Define and Justify the Research Gap Conduct a thorough review of the current literature—including ICH Q10, WHO TRS, and recent empirical studies—and articulate a specific, demonstrable gap that this work addresses. The research gap must be supported by citations showing what is known and what remains unresolved.

R-3: Operationalize Research Objectives Revise research objectives to be specific, measurable, and achievable within the scope of the chosen methodology. Each objective should correspond to a defined analytical component of the study.

R-4: Develop a Rigorous and Transparent Methodology If pursuing a systematic review: document search strings, databases, date ranges, PRISMA flow diagram, inclusion/exclusion criteria, and quality appraisal scores. If pursuing empirical research: describe sampling strategy, data collection instruments, analytical methods, and ethical approvals.

R-5: Produce a Genuine Results Section Generate and present findings that emerge from the methodology. These may be thematic findings from a systematic review or data from primary research. Results must be distinct from the Discussion.

R-6: Develop a Substantive Discussion Link findings to existing literature. Critically compare your results against ICH Q10, FDA guidance, and peer-reviewed studies. Acknowledge limitations transparently. Propose future research directions that are specific and feasible.

R-7: Expand and Verify the Reference List Include a minimum of 30–50 current, peer-reviewed references. Prioritize ICH guidelines, FDA/EMA regulatory documents, and empirical studies published within the last ten years. Verify the existence and accuracy of all cited sources prior to resubmission.

R-8: Revise the Abstract Rewrite the abstract in accordance with structured abstract guidelines: Background, Objective, Methods, Results, and Conclusions. Remove self-referential phrasing.

R-9: Add Visual Frameworks Develop at least one original conceptual model, framework diagram, or comparative table that synthesizes the manuscript's contribution and distinguishes it from existing models in the literature.

R-10: Language Editing The manuscript requires thorough professional editing for grammar, syntax, punctuation, and consistency of terminology. The author should consider engaging a qualified English language editing service prior to resubmission.

Competing interests

The authors declare that they have no competing interests.

Use of Artificial Intelligence (AI)

The authors declare that they used generative AI to come up with new ideas for their review.