Prompt for OOS investigation review

Review this OOS investigation document aensure compliance with pharmaceutical industry standards, US FDA, MHRA, and EU GMP OOS guidelines.

1. Does the investigation include a clear problem statement covering the 5W2H principle? If not, explain what is the issue and what are the suggestions.
2. Perform a hygiene check for spelling, grammar, word and terminology consistency, typographical errors, etc.
3. Does the investigation discuss or cover the necessary and fundamental topics, such as the affected product or materials, supporting evidence of the event, impact on other products, batches, or materials, evaluation of patient safety risk, interviews with the analyst or personnel involved in the event, and the correct tools to perform the investigational analysis (e.g., Why-Why, Fishbone Diagram, checklist, etc.)? If not, explain what is the issue and what are the suggestions.
4. Is the hypothesis plan in the investigation scientifically sound and supported by a written justification for choosing the defined hypothesis? If not, explain what is the issue and what are the suggestions.
5. Is the root cause identified in the investigation supported by data or evidence? If the product has a confirmed OOS, has a Phase II investigation been conducted? If not, explain what is the issue and what are the suggestions.
6. Based on the entire investigation, what are the probable reasons for the OOS, and what potential errors could have occurred during the analysis? Explain, suggest if any deficiency is identified, provide recommendations. 
7. Is the proposed CAPA linked to the root cause or probable cause, and will it effectively address the issue to prevent recurrence? If not, explain what is the issue and what are the suggestions.
8. Does the summary and conclusion provide a brief overview of the event, root cause, and proposed CAPA, and explain how the event will be prevented from recurring? If not, explain what is the issue and what are the suggestions.
9. Does the investigation meet the requirements specified in the regulatory guidelines by the US FDA, MHRA, and EU? If not, explain what is the issue and what are the suggestions.
10. This is applicable for only stability study testing. In case the OOS is related to stability sample analysis, is the impact on distributed product has been assessed? In case of OOS in not invalidated in 72 working hours, FAR was initiated? Explain what is the issue and what are the suggestions.
12. Provide Gaps and overall improvement recommendations.

Format output in markdown.

Prompt for deviation investigation review

Review this deviation investigation document and ensure compliance with pharmaceutical industry standards, US FDA, MHRA, and EU GMP guidelines.

1. Does the investigation include a clear problem statement covering the 5W2H principle (Who, What, When, Where, Why, How, and How much)? Is the deviation event clearly described? If not, explain what is the issue and what are the suggestions.
2. Perform a hygiene check for spelling, grammar, word and terminology consistency, typographical errors, etc. Ensure that all documentation is accurate and consistent.
3. Does the investigation discuss or cover the necessary and fundamental topics, such as, Affected product or materials? Supporting evidence of the event? Impact on other products, batches, or materials? Evaluation of patient safety risk? Interviews done with personnel involved in the event? Use of correct tools for analysis (e.g., Why-Why, Fishbone Diagram, checklist)? If not, explain what is the issue and what are the suggestions.
4. Is the root cause identified in the investigation supported by data or evidence? Does investigation covers description of the process or equipment involved in the deviation. If not, explain what is the issue and what are the suggestions.
5. Does investigation covers a review of similar past deviations or issues. If not, explain what is the issue and what are the suggestions.
6. Based on the investigation, what are the probable reasons for the deviation? What potential errors could have occurred during the activity or process? Explain what is the issue and what are the suggestions.
7. Does investigation covers the impact assessment of the deviation on the product's Safety, Integrity, Strength (potency), Purity, and Quality (SISPQ). If not, explain what is the issue and what are the suggestions.
8. Is the proposed Corrective and Preventive Action (CAPA) linked to the root cause or probable cause? Will the CAPA effectively address the issue to prevent recurrence? If not, explain what is the issue and what are the suggestions.
9. Does the summary and conclusion provide a brief overview of the event, root cause, and proposed CAPA? Does it explain how the event will be prevented from recurring? If not, explain what is the issue and what are the suggestions.
10. Does the investigation meet the requirements specified in the regulatory guidelines by the US FDA, MHRA, and EU? If not, explain what is the issue and what are the suggestions.
11. Provide Gaps and improvement recommendations. 

Format output in markdown.
		

Prompt for customer complaint investigation review

Review this customer complaint investigation document and ensure compliance with pharmaceutical industry standards, US FDA, MHRA, and EU GMP guidelines.

1. Does the investigation include a clear problem statement following the 5W2H principle (Who, What, When, Where, Why, How, and How much)? Is the complaint event clearly described with relevant details? If not, explain what is the issue and what are the suggestions.
2. Perform a hygiene check for spelling, grammar, terminology consistency, and typographical errors. Ensure all documentation is accurate, consistent, and well-structured.
3. Does the investigation discuss or cover the necessary and fundamental topics, such as: Affected product or materials? Supporting evidence (e.g., customer samples, batch records, complaint history)? Receipt and verification of the complaint sample? Review of retained control samples for comparison and verification? Impact on other products, batches, or materials? Evaluation of patient safety risk? Interviews with personnel involved in handling the complaint? Use of appropriate analytical tools (e.g., Why-Why Analysis, Fishbone Diagram, checklist)? Scientifically sound hypothesis with written justification?  Explain what is the issue and what are the suggestions.
4. Is the root cause identified and supported by data or evidence? If related to raw materials or packaging components, has an investigation been initiated with the supplier? Does the investigation cover a description of the process, equipment, and handling involved in the complaint?
n5. Does the investigation include a review of similar past complaints or issues to identify recurring trends? \n6. Based on the investigation, what are the probable reasons for the complaint? What potential errors or failures could have occurred during manufacturing, packaging, storage, or distribution?  Explain what is the issue and what are the suggestions.
7. Does the investigation assess the impact of the complaint on the product's Safety, Integrity, Strength (Potency), Purity, and Quality (SISPQ)? Is there an evaluation of potential risks to the patient?  If not, explain what is the issue and what are the suggestions.
8. Is the proposed CAPA directly linked to the root cause or probable cause? Will the CAPA effectively address the issue and prevent recurrence? \n9. Does the summary and conclusion provide a brief yet comprehensive overview of the complaint, root cause, and proposed CAPA? Does it explain how recurrence will be prevented?  If not, explain what is the issue and what are the suggestions.
10. Does the investigation meet the regulatory guidelines and requirements of the US FDA, MHRA, and EU GMP regulations? Are all compliance aspects well-documented and aligned with industry best practices?  If not, explain what is the issue and what are the suggestions.
11. Provide Gaps and improvement recommendations.
 
Format output in markdown.

		

Prompt for SOP review

Review this Standard Operating Procedure (SOP) and ensure compliance with pharmaceutical industry standards, US FDA, MHRA, and EU GMP guidelines.

1. Perform a hygiene check for spelling, grammar, terminology consistency, and typographical errors. Ensure all documentation is accurate, consistent, and well-structured.
2. Is the SOP title, SOP number, version number, and effective date clearly mentioned? Does the SOP include the department name and approval details? Does it clearly state the objective of the SOP and its applicability (departments, personnel, etc.)? Are technical terms defined to avoid misinterpretation? Does it list relevant guidelines, standards (e.g., USFDA, MHRA, WHO, ICH, EU-GMP, PIC/S, etc.), and related SOPs? Explain what is the issue and what are the suggestions.
3. Is the procedure detailed yet easy to follow? Does it use simple language, active voice, and logical sequencing? Does it clearly define who performs each action? Are responsibilities for execution, review, approval, and training specified? Are flowcharts, diagrams, or decision trees included for better understanding? Are required safety instructions, PPE requirements, risk factors, and emergency actions specified? Are acceptable limits for critical parameters defined? Does the SOP explain how to handle deviations, failures, and corrective actions? Are record-keeping requirements (format, retention period) clearly specified? Explain what is the issue and what are the suggestions.
4. Is the SOP legible with no overwriting, and are errors corrected properly? Is the date/time format standardized (DD MMM YYYY)? Is the SOP signed by authorized personnel? Does it ensure contamination control, validation, qualification, hygiene practices, and traceability? Does it follow the ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) data principles? Are links to related SOPs (batch processing, cleaning, validation, change control, etc.) included? Explain what is the issue and what are the suggestions.
5. Is the document easy to navigate, search, and understand? Are bullet points, numbering, and bold headings used for clarity? Is there a consistent font size, proper spacing, alignment, and section breaks for readability? Are key steps summarized in tables or highlighted for easy access? Explain what is the issue and what are the suggestions.
6. Is the SOP reviewed at defined intervals? Is the version history properly documented? Has the SOP been reviewed and approved by QA, department heads, and compliance teams? Is the SOP reviewed at least once every three years or whenever changes occur? Explain what is the issue and what are the suggestions.
7. Are ambiguities, missing steps, or unclear instructions identified and addressed? Explain what is the issue and what are the suggestions.
8. Does SOP is inline with current Compliance requirement pf pharmaceutical industry regulatory standards, Alignment with current best practices. Explain what is the issue and what are the suggestions.
9. Provide Gaps and improvement recommendations. Explain what is the issue and what are the suggestions.
 
Format output in markdown.

		

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