Good Documentation Practices

1.0 PURPOSE:

To define procedures for housekeeping, cleanliness, and maintenance in the laboratory.

2.0 SCOPE:

This standard operating procedure provides the procedure for Good Document Practices in Quality. Assurance Department.

3.0 RESPONSIBILITY:

Head of Department of QA Department is responsible for the implementation of this SOP.

4.0 DISTRIBUTION

The Quality Assurance department is responsible to keep SOP ‘Master Copy’ approved through Authorized Persons. The copy of the ‘Control Copy’ of SOP is being distributed in the department and placed near related Equipment /Instrument.

5.0 DEFINITIONS & ABBREVIATIONS :

Abbreviations :

SOP: Standard Operating Procedures

5.1.3 QAD: Quality Assurance Department

Definitions:

Not Applicable

6.0 PROCEDURE

6.1 In a facility that uses Good Manufacturing Practices (GMP), numerous types of documentation exist and serve a variety of functions. Examples of the functions of documentation include providing a record of what was done, instructing an individual on how to perform tasks, defining specifications, ensuring traceability, and providing evidence that a product was made according to regulatory or in-house requirements.

6.2 Use indelible blue ink when making entries. All the entries must be clear and legible. Remember that your audience includes not only you and your supervisor but also thecompany's regulatory and QA employees, patent attorneys, and FDA and other regulatory agency investigators who may be reviewing your data years after you record it.

6.3 Do not leave any column in the record/document unfilled. Ifany column in a recorded document is not applicable, write “N.A.”. If no comments write nil or Put.

6.4 Time should be expressed, as HH.MM i.e. 2 pm should be recorded as 14.00hrs.

6.5 Date should be expressed as DD/MM/YY or DD/MM/YYYY.

6.6 If any page(s) is left blank, draw a line across the page from left top to right bottom of the page and write “CANCELLED” /“N.A.” (Not Applicable) across the page and sign with a date.If an entire page/paragraph is to be canceled from a document. A Head of Department countersign is required. No Pencil entries are allowed.

6.7 Do not use correction fluid in any of the documents.

6.8 All personnel shall avoid errors during data entry.

6.9 In case an entry error occurs, the same shall be corrected as, Do not overwrite the wrong entries, cross it out with a line permitting the reading of the original entry, clearly write the correct entry near the cross out and put the Initial/signature with the date on which the correction was made.

6.10 If the correction is made on a date after the date of the original entry, it must be corrected as mentioned above and counter-signed and dated by the head of the department.

6.11 Removal of page(s) is not permissible.

6.12 The addition of page numbers like “page x(X) of y(Y)”allows a reviewer to ensure that there are no missing pages.

6.13 If applicable, the analytical record must have information about, the name of the instrument, Identification no. of Working/ Reference / Primary standard used for analysis.

6.14 Procedure of recording the weight in the record should be in a manner to ensure the correct and accurate weight, like a Gross weight than tare weight, and finally calculate the netweight of the material.

6.15 All the records check and review in a manner to ensure the correctness of records.

6.16 Name and designation must be present with the initial/signature and date of analyzed/prepared by, checked by, and reviewed/approved by.

6.17 In a continuous sheet every page must have the Initial/signature along with the date Analyzed/prepared by and checked by, the last page must have the complete detail of the Initial/Signature, Date, Name, and designation.

6.18 Attach graphs, charts, and so on to record. When unfolded, attached documents should be within the confines of the opened record.

6.19 Log books of each operating instrument in a format or register must be updated & checked online.

6.20 Daily monitoring records must be updated & checked at the time of monitoring to represent the actual work done.

6.21 Labeling on instrument, container, or record in a way to ensure the complete information according to their standard procedure only.

6.22 Only control format is applicable for use, In the case of Registers, issued by QA having the page no. of each page.

6.23 Storage of documents must be in a manner of traceability &safety.

6.24 Printing the document or photocopy shall be clear and without any missing information of the original document/record.

6.25 Use good scientific methods. Narrow scientific variables toone, strive for reproducibility, accuracy, and precision

6.26 Use approved methods, and compendial methods whenever available. Validate noncompendial methods.

6.27 Reference methods, specifications, chromatographic data, and chart books. Include document numbers, effective dates, and revision numbers for controlled documentation.

6.28 Initials are acceptable in place of a signature if the initials are on file and if this practice is written and approved in the company's SOPs.

6.29 Avoid negative and extraneous comments. Do not state your opinion. Be factual.

6.30 No entries should be made beneath the attached sheets, and nothing should be obscured.

6.31 If data are not kept in the record, they must be checked, signed, dated, and identified to provide a reference back to the pertinent page of the laboratory record.

6.32 Lab records must not be copied without the Head of Department's knowledge and approval.

6.33 Correction on printed documents is not allowed.

6.34 Every record must be assigned a unique number.

6.35 Lab records are confidential and are the property of the company. Multiple, completed records should not be kept in the researcher's or analyst's work area. Filled records should be returned to company archives for proper storage.

6.36 All employees must have documented training in record procedures and in any revisions to those procedures.

6.37 Keep the records clean, safe, and traceable.

7.0 PRECAUTIONS

Not Applicable

8.0 REFERENCES & FORMATS :

REFERENCES:

In house

ORMATS

Format-I: Format for Document History Sheet

9.0  REVISION HISTORY

Maintain the history of SOP or document as per the format given in. It shall be maintained along with the current version of the SOP.