Good Documentation Practices (GDP)|GMP Basic-likeways

1. Organization Name No.: SOP number Effective Date: Next Review Date: Supersede s No.: Dated: Logo STANDARD OPERATING PROCEDURE Title: GOOD DOCUMENTATION PRACTICES 1.0 PURPOSE: To establish good documentation practices that include entries and corrections to documents, responsibilities, and training requirements. 2.0 SCOPE: The procedure outlines the only acceptable way to make entries and corrections to the documents, product batch records, laboratory records, product manufacturing documents, and reports. 3.0 RESPONSIBILITY: All employees who are involved in document entries and/or corrections are responsible for recording accurate information. 3.1. It is the responsibility of the department head to ensure that all new employees receive initial training on this procedure. 3.2. 4.0 DEFINITIONS: Document: This is the official record or report that supports and /or records the activities for development, inspection, testing, handling, and distribution of raw materials, components, in-process materials, and finished products. Examples include but are not limited to Batch records, logs, protocols, reports, etc. 4.1 Done by: Person that performs specific functions, tasks, or steps. 4.2 Checked by: Person that cross-checks specific functions, tasks, or steps done by the other employee. 4.3 Verified by: Person other than the original person who performs or documents the specific function, task, or step. Verification means to confirm or substantiate, to establish the truth, accuracy, or reality of the recorded entries or observed practice, machine setup, measurable values, etc. 4.4 Correction: a modification and/or change to any entry within the document. 4.5 Additional Issuance: Document added to the batch record after it is issued by t h e QA department. 4.6 Omission: Information not recorded at the time of performance. Name/E-sign 4.7 Signatories Prepared By Checked By Approved By Department: Quality Assurance Designation Date and Time Page 1 of 5

2. Organization Name No.: SOP number Effective Date: Next Review Date: Supersede s No.: Dated: Logo STANDARD OPERATING PROCEDURE Title: GOOD DOCUMENTATION PRACTICES 5.0 PROCEDURE: 5.1 GENERAL CRITERIA: 5.1.1 All documents should be designed, prepared, reviewed, and distributed as per the current version. 5.1.2 Ensure correct versions of records are used for data recording 5.1.3 Documents should be approved, signed, and dated by the concerned authorized signatories. 5.1.4 Documents should have unambiguous contents and titles scope and purpose should be clearly stated. 5.1.5 Documents should be laid out in an orderly fashion and should be easy to check. 5.1.6 Do what is written in the procedures and document what you do. 5.1.7 All entries must be made only in a blue ball pen. Use of any other pen such as a roller ball or gel pen is prohibited. DO NOT use pencil, erasable ink, or correction fluid. 5.1.8 All entries must be legible and entered on the document at the time the function/activity is being performed. DO NOT document in advance, backdate, or pre-date any information. 5.1.9 All entries must be signed/initiated and dated properly. Specific requirements are noted in each document. Staff are not permitted to sign for another member of staff unless delegated. 5.1.10 No entry shall be overwritten. 5.1.11 Record data directly on the designated records. It is unacceptable to document information on scrap paper, post-it-note or other materials that are not part of the record. 5.1.12 Documents and records should be reviewed by someone who did not perform the task to ensure that the information is correct and accurate. A signature and date by the reviewer or approver confirm that a review has taken place. Unsigned documents or records are incomplete and should not be used to perform any task or considered as evidence of a completed task. 5.1.13 When a correction and/or comment is to be made, those should be done by each person individually. Never add onto someone else’s correction. Signatories Prepared By Checked By Approved By Department: Quality Assurance Name/E-sign Designation Date and Time Page 2 of 5

3. Organization Name No.: SOP number Effective Date: Next Review Date: Supersede s No.: Dated: Logo STANDARD OPERATING PROCEDURE Title: GOOD DOCUMENTATION PRACTICES 5.1.14 Modification and/or changes to an SOP, specification, or batch record document are not allowed without review and approval by QA; a deviation may be required to document the error. 5.1.15 Ditto marks are not acceptable. 5.1.16 Columns of data cannot be extended by use of quotation marks. 5.1.17 All the documents/records should have page numbers using the following standard ‘X of Y’ to indicate the total number of pages in a document. 5.1.18 All printouts made on thermal paper must be copied before attaching to a report or filing with sign and date. After making a copy attach the original and the copy with the report. 5.1.19 Definitions of abbreviations should always be included in the document for reference. 5.1.20 There should be no intentional misrepresentation and/or fabrication of data. 5.1.21 Deliberately amending or destroying GMP records to hide or falsify data is fraud. 5.1.22 GMP records should not be discarded for any reason unless the retention period expiry is reached. 5.1.23 If the information asked for in a particular instruction/column does not apply to the activity performed, the words ‘NA’ should be written against such instruction. If the information is asked for in the case of a complete section complete table or complete page then ‘NA’ shall be written against such instruction, a diagonal line shall be drawn across the section table or page, and shall be initialed with a date. 5.1.24 If an option is provided in the form, the applicable option shall be selected by crossing out the non- applicable option e.g. Required/Not required. If the option is to be indicated in the boxes provided in the document, the applicability shall be indicated by putting a tick mark (√) in the appropriate box. Note: 1) Tick mark (√) SHOULD NOT be used instead of crossing out the non-applicable option and vice-versa wherever applicable (unless it is mentioned to do so) 5.1.25 Obtaining approval signatures from staff located at different sites/locations can be completed using scanning rather than hardcopy: 5.1.26 Print the document to be approved. 5.1.27 Sign and date the hard copy and then scan the hard copy with the signature. 5.1.28 The pdf file of the scan is emailed to the appropriate signatories, who sign and date their signature field in each printout of the pdf file and then rescan the document and email it back to the preparer. Signatories Prepared By Checked By Approved By Department: Quality Assurance Name/E-sign Designation Date and Time Page 3 of 5

4. Organization Name No.: SOP number Effective Date: Next Review Date: Supersede s No.: Dated: Logo STANDARD OPERATING PROCEDURE Title: GOOD DOCUMENTATION PRACTICES 5.1.25.4 The coordinator receives a PDF file from each signatory indicating their approval. 5.1.25.5 Attach the signatory page from each approver to the original hard copy. 5.1.29 If any hard copy of the document is required to be given to an outside agency to another site of Micro- labs each page of each copy should be stamped with UNCONTROLLED COPY. 5.1.30 If any scanned copy of the document is required to be given to an outside age or another site of Micro- labs each page of each copy should be stamped with an UNCONTROLLED COPY and scanned document and email. 5.2 REQUIREMENTS FOR RECORDING DECIMAL NUMBERS AND ROUNDING OF VALUE: If a decimal value is a fraction of 1 then a zero must be placed before the decimal point. 5.2.1 Example: record 0.95 rather than .95 The number of decimal places to be recorded should be as per specification. 5.2.2 Example: When a specification limit is 2.55-2.85 and the result is 2.7 then record the result as 2.70 and not 2.7. When rounding off is required, consider only one digit and apply the following rules: 5.2.3 If the digit is smaller than 5, then the preceding digit is unchanged. 5.2.3.1 If the digit is equal to 5, then the preceding digit is increased by one. 5.2.3.2 If the digit is greater than 5, then the preceding digit is increased by one. 5.2.3.3 Rounding of price value (printed on the packing material) shall not be done. 5.2.4 The reading of instruments shall be recorded as displayed on the instrument. 5.2.5 5.3 REQUIREMENTS FOR TIME AND DATE: When a date is recorded, the acceptable format is DD/MM/YY only, where DD stands for 5.3.1 date, MM stands for month and YY stands for the last two digits of the year. Example: 12/08/14. Time is recorded in 24:00 hour time (24 hr. clock), where 00:00 is midnight and noon is noon. 5.3.2 Signatories Prepared By Checked By Approved By Department: Name/E-sign Designation Date and Time Page 4 of 5

5. Organization Name No.: SOP number Effective Date: Next Review Date: Supersede s No.: Dated: Logo STANDARD OPERATING PROCEDURE Title: GOOD DOCUMENTATION PRACTICES Time in 24hrs format Time in 24hrs format Time in 24hrs format Time in 24hrs format Time Time Time Time 12:00am 00:00 7:00 am 07:00 2:00 pm 14:00 9:00 pm 21:00 1:00 am 01:00 8:00 am 08:00 3:00 pm 15:00 10:00 pm 22:00 2:00 am 02:00 9:00 am 09:00 4:00 pm 16:00 11:00 pm 23:00 3:00 am 03:00 10:00 am 10:00 5:00 pm 17:00 4:00 am 04:00 11:00 am 11:00 6:00 pm 18:00 5:00 am 05:00 12:00 pm 12:00 7:00 pm 19:00 6:00 am 06:00 1:00 pm 13:00 8:00 pm 20:00 For documentation of production activities time is recorded from calibrated Hygrometers or 5.3.3 digital clock for each process step from start to finish. 5.4 REQUIREMENTS FOR CORRECTIONS, UNUSED SPACES AND DATA TRANSCRIPTION: When an erroneous entry is made or discovered within a document, such errors shall be 5.4.1 corrected. Correction to an original is acceptable for obvious errors before the approval of the document. 5.4.2 Examples of obvious errors include, but are not limited to: a missed initial, date, calculation error, transcription error, etc. Corrections made by an individual other than the person who made the original entry shall be 5.4.3 limited to obvious errors. Corrections of non-obvious errors in production batch records are acceptable only when 5.4.4 accompanied by a justification and/or proof of the correction by verification against an appropriate reference document. The corrective actions should be approved by the A Head. Additionally, if observations/deficiencies reveal an impact on quality and/or require the replacement of pages such corrective actions should be handled through deviation investigation with instructions of QAP, Handling of Deviations, Signatories Prepared By Checked By Approved By Department: Name/E-sign Designation Date and Time Page 5 of 5

6. Organization Name No.: SOP number Effective Date: Next Review Date: Supersede s No.: Dated: Logo STANDARD OPERATING PROCEDURE Title: GOOD DOCUMENTATION PRACTICES It will continue… Get ready to use editable documents in MS Word Format (Regulatory standard SOPs) Only Rs-49₹/- Contact: Email: contact@likeways.co.in WhatsApp/Telegram No: +919738137533 (Only for Message) Note: Kindly note that you will receive the document through email only after the payment has been completed. Please send the screenshot of your payment confirmation via WhatsApp/Telegram. A payment QR code will be provided from our end.