sop for good documentation practices
1.0 OBJECTIVE
1.1 The objective of this SOP is to define the procedure for enable the company to demonstrate conformance to both internal and external standards with documentation.
2.0 SCOPE
2.1 This SOP is applicable for doing good documentation practices related with records certifying follows up of standard practices, procedures, policies and work sheet used for recording of raw data during an analysis or observation, inter office memos, notes, reports, chromatograms, spectra, integrals, evaluation or measurement results raw data also includes maintenance & calibration records of instrument, recording in BMR, BPR and other relevant manufacturing documents sample receipt and distribution record for test and other recording of observations used to demonstrate conformance of requirements
3.0 RESPONSIBILITY
3.1 Asst. Officer or above -Quality Assurance – Prepare the SOP and follow-up the SOP accordingly.
3.2 Asst. Manager-Quality Assurance / Production -Provide the support to the implementation of SOP and maintained the records.
4.0 ACCOUNTABILITY
4.1 Head – Quality Assurance Department
5.0 REFERENCE(S)
5.1 cGMP / In-House
6.0 PROCEDURE
6.1 Forms: Data collection sheets usually accompanying a standard operating procedure and protocols
6.2 Log books and Notebooks: Log books and notebooks should be permanently bound with unique page numbers where results of inspections and test procedures are documented.
6.3 Vendor Documentation: Any certificates, forms, or other documentation supplied by vendors to demonstrate that they have completed a specific regulated task should be reviewed and signed.
6.4 Designee: A person who has been given the authority to sign for another person. This must be established in a standard operating procedure. This person must have the knowledge
6.5 Responsibilities: Operations, Engineering, Production formulation and development Stores & QC are responsible for following this procedure when completing documentation supplied by document control:
6.5.1 Individual concerned department is responsible for following this procedure when creating, verifying, or completing documentation supplied by document control.
6.5.2 Q.A department is also responsible for following this procedure during issuance of documents.
6.6 Document Numbering: Each & every document is assigned in the with a unique number so that all papers of a single document can be identified easily.
6.6.1 All documents shall have a unique document number issued by QA, depending on the specific standard operating procedure prior to issuance.
6.6.2 Every page of a document shall be marked with the page number as well as the total number of pages in the document. If a document is a single page, this section can be omitted.
6.6.3 All documents shall have a revision number as defined in their specific standard operating procedure
6.7 Document Effective Date and Valid Up To:
6.7.1 All documents shall have an effective date and valid up to………. It is very important that old documents shall not be used when new documents have been implemented.
6.7.2 The effective date notation shall be identified in a procedure. As Date/Month/Year. e.g. XX/YY/ZZ.
6.8 Documents should have a title as it is helpful in finding out the said documents when needed.
6.9 All the documents shall be listed and indexed.
6.10 Document Changes:
6.10.1 All documentation changes must be carefully documented, reviewed, and approved.
6.10.2 Corrections /Additions:
6.10.2.1 Correction in the approved or filled documents shall be done after getting approved from concerned department and Head-QA.
6.10.2.2 Single cut the word/data to be changed by blue ball pen (Single cut shall be in such a way that original data should be legible).
6.10.2.3 Data corrected must be duly dated and signed by the concerned person.
6.10.2.4 If data to be corrected exceeds more than one line, then sign should be made on top of the word where correction begins and on the work and where correction is finished.
6.10.2.5 If correction made is significant with respect to the subject of the document, the concerned person should write the reason for corrections near the corrected word / data.
6.10.2.6 All corrections or additions shall be signed and dated.
6.10.2.7 Only personnel who have already been approved to author or make changes to documents can correct or add something in to a document.
6.10.2.8 Corrections shall be made by drawing a single line through the incorrect data and shall be signed with date, footnote for the corrections shall be made explaining reason for corrections in the same page.
Example:
ppm
200 * 400
210* 420
220* 440
240* 480
* Data has been corrected due to error in dilution factor.
6.10.2.9 Head-QA or his designee shall correct the master document with sign and date.
6.10.3 Comments: Non-typographical error corrections or additions indicating a change in data or acceptance status require a comment.
6.10.4 Approval:
6.10.4.1 Typographical error changes or additions do not require approval. For example, writing in the wrong date do not require approval.
6.10.4.2 Non-typographical error changes / additions are routed through a full document change control. For example, changes to a specification or requirement in a document do require re-approval.
6.10.4.3 Pencil shall not be used for corrections.
6.10.4.4 Only blue ball pen used in the documentation activity (and green pen used only IPQA activity) and Gel pen shall not be used anywhere.
6.10.4.5 No over writing shall be made.
6.10.4.6 No use of erasers.
6.10.4.7 Correction fluid is not accepted.
6.10.4.8 Any types of corrections are not allowed in any document’s controlled copy.
6.10.4.9 Obvious blank space should be filled with “NA”.
6.10.4.10 Ditto mark e.g. “”” of “do” are not acceptable.
6.10.5 Document Signatures:
6.10.5.1 All documentation used to provide evidence that standards are being followed must be signed with date.
6.10.5.2 Origination:
6.10.5.2.1 All documents shall be signed by the originator.
6.10.5.2.2 No signature pads, scanned signatures, or duplicated original signatures shall be used to replace a handwritten signature by the person signing.
6.10.5.2.3 Signature & date shall be put with good quality of ink as it is essential to maintain the signature on a documents till further it’s life.
6.10.6 Page Cancellation: Word “Cancelled” should be write on the paper and made by drawing a single line through the page, it shall be signed with date, description requires a statement, footnote for the canceled made, explaining with date the reason of correction on the same page.
6.10.7 Review:
6.10.7.1 All documents requiring verification shall be signed by the person verifying.
6.10.7.2 Documents requiring approval shall be signed.
6.10.7.3 An approved list of designees, originators, and reviewers shall be maintained.
6.11 Designees:
6.11.1 If a designee is to be used, then that person signs his/her name, adds the words “signing for”.
6.11.2 Designees must have the knowledge, skills, and abilities to perform the assigned authorship, verification, or approval activity.
6.12 Date:
6.12.1 Current version of format shall be used and observation of current date shall be recorded.
6.12.2 Back dated recording (entering a date on a day after the entry was made or the task was performed) is not permitted.
6.12.3 For time 24 hrs system shall be used. e.g. 8:00 AM = 8:00 and 8:00 PM = 20:00.
6.12.4 Any changes in any documents after it’s implementation (based on observation during it’s execution) must be rerouted for approval.
6.12.5 Documents that have not been completed and signed off are still considered drafts.
7.0 ABBREVIATIONS
SOP : Standard Operating Procedure
QA : Quality Assurance