Transcription of TGA Sciences Quality Assurance Documentation System
1 TGA Sciences Quality Assurance Documentation System TITLE DOC NUMBER Good Documentation Practices GP-08-01 VERSION NUMBER T-002 EFFECTIVE DATE SUPERSEDES LOT NUMBER PAGE NUMBER May 6, 2013 May 21, 2007 N/A 1 of 3 NOTICE THIS DOCUMENT IS PROPRIETARY AND ITS CONTENTS ARE THE EXCLUSIVE PROPERTY OF TGA Sciences , INC. THIS DOCUMENT MAY NOT BE REPRODUCED IN ANY FORM WITHOUT PRIOR WRITTEN PERMISSION FROM TGA Sciences , INC. PURPOSE AND INTRODUCTION This procedure describes the minimum and not all inclusive Documentation requirements for all personnel completing GxP documents for TGA Sciences , Inc. This includes the following: All Controlled forms All Controlled logbooks All Instrumentation Charts All Laboratory Notebooks All Bound Record Books All Controlled worksheets REFERENCED DOCUMENTS GP-01-02: Deviations Procedure RESPONSIBILITIES It is the responsibility of all laboratory personnel to use proper Documentation practices in their work as outlined by this procedure.
2 It is the responsibility of the QA to review Documentation for compliance with this procedure. DEFINITIONS Not applicable EQUIPMENT AND MATERIALS Not applicable PROCEDURE Documentation Basic Elements Documentation requires specific guidance for the type of ink used on paper, how to record dates properly and even how to record the time the event occurred. Documentation must be clear so any abbreviations must be explained. Having blank entries needs some clarification so no one can come back and put information in after the fact. Blue or black indellible ink must be used at all times. TGA Sciences Quality Assurance Documentation System TITLE DOC NUMBER Good Documentation Practices GP-08-01 VERSION NUMBER T-002 EFFECTIVE DATE SUPERSEDES LOT NUMBER PAGE NUMBER May 6, 2013 May 21, 2007 N/A 2 of 3 NOTICE THIS DOCUMENT IS PROPRIETARY AND ITS CONTENTS ARE THE EXCLUSIVE PROPERTY OF TGA Sciences , INC.
3 THIS DOCUMENT MAY NOT BE REPRODUCED IN ANY FORM WITHOUT PRIOR WRITTEN PERMISSION FROM TGA Sciences , INC. Recording dates the US nomenclature Month/Day/Year is the format to follow. If you choose to put the day/month/year which is the European format, then you must spell out the month either in full or as an abbreviation. Time formats can either be military (24 hour cycle) or standard using AM or PM. If standard time formats are used, the AM/PM designation MUST be indicated. Abbreviations should be easily recognizable as terms related to our industry. It is always a good practice to initially show the full word and then show the abbreviation. Lining out documents or sections is permissible providing the owner or person making the decision initials and dates the N/A line-out. Making Error Corrections Never obliterate a data entry. If it is incorrect, draw a thin line through the error and initial and date it.
4 Some errors are easily understood as to why they are errors. Those that are not easily understood must have a written explanation using one of the common abbreviations below: DE (Document Error) this may be used if there is an error in the document. QA should be notified in order to correct and revise the document as soon as possible. EE (Entry Error) this may be used if the author accidentally writes something wrong or mis-spells a word CE (Calculation Error) this may be used if the author initially records an incorrect number and the mistake is realized before the procedure is actually performed. NOTE: If the procedure is actually performed with a calculation error then a deviation should be initiated. DO NOT cross out a calculation error after the procedure has been performed. WO (Write Over) this may be used if the initial entry is illegible due to poor handwriting or pen error.
5 A write over can also be used interchangeably with an entry error. VC (Volume Change) this may be used to indicate a changed volume in a procedure provided the ratio of ingredients or calculation does not change. For example: In a procedure it is indicated to dilute 5 L of component A into 45 L of component B however additional volume is required so you dilute 10 L of component A into 90 L of component B. ^ (carrot symbol or insert indication) this may be used to insert additional text to a procedure. Any inserted text should also be initialed and dated. Do not write over a number or letter to correct it. Do not try to make a 5 into a 6 of a 6 into an 8 (This is an example of a Write Over) The error maker should be the one to correct the error. If that person cannot be found, then management approval is required for the correction. Do not void or rewrite a document.
6 When damage to documents occurs, keep in mind that you always want to retain that original raw data document even if it has grease and dirt on it. TGA Sciences Quality Assurance Documentation System TITLE DOC NUMBER Good Documentation Practices GP-08-01 VERSION NUMBER T-002 EFFECTIVE DATE SUPERSEDES LOT NUMBER PAGE NUMBER May 6, 2013 May 21, 2007 N/A 3 of 3 NOTICE THIS DOCUMENT IS PROPRIETARY AND ITS CONTENTS ARE THE EXCLUSIVE PROPERTY OF TGA Sciences , INC. THIS DOCUMENT MAY NOT BE REPRODUCED IN ANY FORM WITHOUT PRIOR WRITTEN PERMISSION FROM TGA Sciences , INC. Falsification Falsification implies entering data/information which was not obtained directly by the originator and the means to collect the information were inappropriate to GxP. The following are examples of falsification which should NEVER occur: Entering data results when testing has not been performed Example: "The balance weight checks are always in specification.
7 I will just write down the value I got last time". Entering data results which are not reflective of the actual reading. Example: The specificiation is supposed to be not less than I got a value. That s close enough" Signing for work prior to that work being performed. Example: "I am going on break at 10 AM and have a check due. So, I will just write the 10AM check in on my Documentation now (9:40 AM), and therefore I can still stay gone at 10 AM." Entering a date other than the current date when documenting completion of a task or comment. Example: I forgot to write in that date for the results I took 3 weeks ago. I know I did it, but just forgot to put the date. I will just backdate it." Using someone else's computer logon and password or allowing someone else to use your logon and password. Example: Lisa's keyboard and screen are active and I don t feel like logging her out.
8 I will just use her log-in to collect my data. Destroying original data or voiding original data without supporting Documentation and proper approval. Example: "These lab results really look funky. They can t be right. I will just get a clean sheet and start over. No need to keep that original data." Verifying a step, task, calculation, or other entry without individual observation. Example: Mike left me alone to prepare this buffer. It calls for him to verify me doing this. Oh well, I have been doing this for 3 months and never made a mistake. I will just initial for Mike. I know its okay." Signing someone else's name. Example: "I know this is Jessica's handwriting. She didn't sign and date her reagent log. I will just write her name in and tell her about it later."
