This is an award winning business plan by the European Union, for the Enterprise fellowship scheme. Business Plan by Syed Masrur, the Founder of the first English speaking Islamic Television Channe...
sheet musicFull description
Full description
Wizards of the Coast sales Magic the Gathering solicitation flyer for the third set of the Scars of Mirrodin block. Code-named 'Action', this set will be properly named 'Mirrodin Pure' or 'New Phyr...
Deskripsi lengkap
Descripción: Buen programa, grabar videos desde tu Pc
1/31/2017
SOP for Corre Correct ctive ive Actio ction n and Preve reven ntive tive Actio ction n (CAP (CAPA) : Pharmace rmaceu utical ical Guid Guide eline lines
SOP for Corrective Action and Preventive Action (CAPA) Standard operation procedure for implementation of corrective and preventive action in different pharmaceutical departments. 1.0 OBJECTIVE: To lay down the procedure for to be be followed for administration of of Corrective and Preventive actions CAPA including tracking and reporting of of CAPA. 2.0 SCOPE: This SOP shall be applicable for track and follow up open CAPA as well as verification of completed CAPA. Corrective action: Action taken to rectify, fix or correct a specific deviation, defect or u ndesirable situation. Preventive action: Action taken to eliminate the cause of deviation, defect, or other undesirable situation in order to prevent the future occurrence of such or similar Source documents of CAPA are identified as: GMP Investigations Deviations Laboratory OOS Investigations Internal Audit Reports External / Customer Audits Annual Product Reviews Regulatory Inspection Reports Management Action Plans Changes in regulatory / Pharmacopoeia requirements Product Failures Complaints Product recall Returned Goods Incidence Reports Discrepancies 3.0 RESPONSIBILITY: All Department Heads 4.0 ACCOUNTABILITY: Head Quality Assurance 5.0 PROCEDURE: 5.1 Source document document shall shall provide provide the the propos proposed ed correc corrective tive and preventive preventive actions. actions. The The propos proposed ed correct corrective ive and prevent preventive ive actions actions shall shall be ap ap QA prior to implementation. The proposed corrective and preventive actions shall be verified during CAPA evaluation in form. 5.2 The "CAPA" form shall be treated as a tracking form of Corrective and Preventive actions from source document. 5.3 Initiation of CAPA: 5.3.1 Department Head shall decide the need for CAPA during initiation of any source document mentioned in Scope. 5.3.2 The Department Head shall get a CAPA form issued from QA. QA. QA shall write the source source document name and Source document number o before issue of form. Record of CAPA form issued shall be maintained by QA. 5.3.3 Department Head shall fill the CAPA form as under. 5.3.3.1 Write the name of the department 5.3.3.2 Date CAPA initiated 5.3.3.3 Proposed completion date 5.3.4 Carry out root cause analysis and write description based on the source document. 5.3.5 Write in brief the CAPA description from the source document and corrective and preventive action details. 5.3.6 The Department Head shall write their name with signature and date. 5.3.7 The department head shall send the CAPA form to QA. 5.3.8 GM GM QA / Designee shall shall allot a reference reference number number to the CAPA form and make relevant relevant entries entries in the CAPA CAPA log. Forward Forward the CAPA fo concerned department. 5.3.9 The CAPA shall be numbered serially serially in the calendar calendar year for each department with an identification code of department. A typical CAPA for numbered as CAPA/XXX/YYY/Z Where, XXX: department code. YYY: serial number, commencing at 001 for each department in calendar year. Z: Last two digits of a calendar year. e.g. CAPA/PRD/007/15 represents the 7th CAPA from production department in calendar year 2015
DEPARTMENT CODES QAD ‐ Quality Assurance Dept. QCD ‐ Quality Control Dept. PRD ‐ Production Dept. WHD ‐ Ware House Dept. ENG ‐ Engineering Dept. http://ww w. w.phar ma magui de del in ine.com /2 /2012/07/sop- fo for -c -cor re recti ve ve- ac acti on on- pr pr ev eventi ve ve- ac acti on on- CA CAPA.htm l
1/3
1/31/2017
SOP for Corrective Action and Preventive Action (CAPA) : Pharmaceutical Guidelines
HRD ‐ Human Resource Dept. PKD ‐ Packaging development Dept. EHS ‐ Environment Health & Safety Dept. 5.4 CAPA Closure and Verification: 5.4.1 On completion of actions, the department head shall certify that the proposed CAPA is completed and implemented along with associated a 5.4.2 QA shall verify the implementation and completion of CAPA with review of supporting documents and certify the same. 5.5 Any change proposed as a result of CAPA shall be through the SOP on Change Control. Reference of the same shall be mentioned in the CAPA 5.6 All Deviations, Discrepancy reports giving rise to CAPA shall be addressed through CAPA form. 5.7 All facility up‐gradations / Capital purchase requirements / major changes in quality system for compliance to regulatory commitments givi CAPA shall be addressed through CAPA form. 5.8 The record of each CAPA shall be maintained. Copy of the completed CAPA shall be provided to the concerned Dept. Head by QA. A copy of CAPA form shall be attached to the source docume 5.9 Department Head shall compile the CAPA information and submit the summary to the Management during GMP Committee meeting / Ma Review Meeting. 5.10 Management shall review / verify the same quarterly in Management Review Meeting. 5.11 Information and documents related to CAPA drawn form internal audits, external/ Customer audits and regulatory inspections are c confidential and can only be made available to regulatory review when approved by Director Technical and Sr. Vice President. 6.0 ABBREVIATIONS: 6.1 SOP: Standard Operating Procedure 6.2 CAPA: Corrective Action and Preventive Action 6.3 GMP: Good Manufacturing Practices 6.4 OOS: Out of S pecification 6.5 GM: General Manager
ANNEXURE‐1 Request form for CAPA Originating Department Name Request No. Present Process / Problem :
Date
Proposed Action If any :
Acceptance Criteria of proposed action :
Approval by Head of Originating Department :
Signature/Date
ANNEXURE‐2 FORMAT FOR CORRECTIVE AND PREVENTIVE ACTION Department Name :‐ Report No. Ref. request No. if any :‐ Description :
Corrective action:‐
Target date of Completion completion Date
Preventive Action :‐ http://ww w.phar magui del ine.com /2012/07/sop- for -cor recti ve- acti on- pr eventi ve- acti on- CAPA.htm l
2/3
1/31/2017
SOP for Corrective Action and Preventive Action (CAPA) : Pharmaceutical Guidelines
Acceptance Criteria :‐
Approval:‐
Head Originating department Sign./Date Implementation and Follow up verified by
Originating department Sign./Date
Head Quality Assurance Sign./Date
Quality Assurance Sign./Date
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely‐read pharma blog since 2008. Sign‐up for the free email updates for your daily dose of pharmaceutical tips. Need Help: Ask Question Online
http://ww w.phar magui del ine.com /2012/07/sop- for -cor recti ve- acti on- pr eventi ve- acti on- CAPA.htm l