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GDocP_GRK documents planned for the traning
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- 2. Be Punctual Show upto the meeting on time so that you're respectful of other people’s time Dress professionally Dressing professionally is vital for success in an office or academic environment. Speak clearly Speak loudly enough and clearly enough so that everyone can understand Actively listen and participate Find a good balance between listening and participating in discussions. A good thumb rule is to listen at least 2x as much as you speak. Give others the opportunity to speak Be patient in waiting for your turn to speak and look for the right cues to contribute to the conversation. Follow the agenda Stay on topic to make your discussion more productive and Ultimately save time. Ask clarifying questions Ask questions at the appropriate time when the question is relevant what is being discussed. Be attentive to your body language Try to avoid actions such as clicking your pen, fidgeting, rustling paper, checking your phone etc. which can seem rude or disrespectful MEETING ETIQUETTE VMB_TR_GdocP_00
- 3. Good Documentation Practices Akey to Good Documentation Practices is to consider these questions each time you record your raw data: Is it true? Is it accurate? Is it timely? Is it legible? VMB_TR_GdocP_00
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- 5. GMP Recordkeeping Categories Primary Records (examples: production formulas, supply source documents, contracts, packaging instructions) Procedures or supporting procedures (instructions and guidebooks, SOPs) Subsidiary records (help meet GMP, e.g., calibration readings reports, print outs, other supporting documents) Quality Control records (testing results, testing methods, recall procedures, investigations, self-inspection reports, CAPA, more) VMB_TR_GdocP_00
- 6. Documents require tofollow GDocP • Certificate of Analyses (CoA) • Certificate of Compliance (CoC) • Bills of Materials (BOMs) • Policies • Validation Documents (IQs, OQs and PQs) • Training Documentation • Standard Operating Procedures (SOP) • Protocols • Quality records • non-conformances • CAPAs • Internal inspection reports • Change control VMB_TR_GdocP_00
- 7. Implementation of GDocP/GRK •Document/Record shall be simple, reliable and accurate. It shall be clear and legible for intended use. • Predefined templates shall be used. • Shall have unique doc. No. • Shall be done with ball point pen, with color coding as per company policy • Page no. in x of y format, to detect any missed/lost pages • Prepared, Reviewed & Approved by qualified & authorized personals, with date, name & signature. • Only controlled docs shall be used from QA. • Data entry shall be done in real time. • Any copy made shall be identified properly (with a stamp/seal etc.) with name, signature, purpose VMB_TR_GdocP_00
- 8. Recording as perGDocP/GRK • Shall be clear, concise, accurate & legible. Shall be done on real time. • Shall be done with ball point pen, with color coding as per company policy. No pencil, erasable/water soluble ink shall be used. • Vacant space is not allowed. Either strike the space or enter NA in vacant space. • Employee signature log need to be maintained with Date, Name, functional domain, Initials & Signature. • Stamp/Seal shall be kept in a secured manned, such a way that unauthorised usage is prevented. • Attachments to the controlled copies shall have reference/report seal with name, signature & date. • Single strike shall be used to rectify errors. Enter the correct value/data near to the strike, with initials, date & brief explanation or error/correction code. VMB_TR_GdocP_00
- 9. Document maintenance • Ifany document is missed, Incident need to be reported to HOD & QA, investigation to be carried out by QA. • Torn/damaged Documents shall not be discarded. • Spillage incident need to be reported to HOD & QA. Document shall be treated same way as torn document. Copy shall be made with date & signature and attached along with the Original torn document. • Documents shall be retained for such a period as per company policy VMB_TR_GdocP_00
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