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Saturday, January 3, 2009

Pharma GMP Check list pharmaceutical manufacturing

WHO GMP Checklist for pharmaceutical manufacturing firm for who gmp inspection for who gmp guideline whoguideline audit compliance cheek list with respect to who gmp guide for quality assuarance gmp for pharmaceuticals guide for pharmaceutical validations,
pharmaceuticals manufacturers guide for gmp

WHO GMP Checklist for pharmaceutical manufacturing firm for caring self audit . To ensure gmp for pharmaceuticals,guide for pharmaceutical validations

Dear friends i wish you all a very happy new year 2009, in today's post I am going to provide you a very helpful piece of document for gmp for pharmaceuticals which will always prove you very helpful,
I have written this by keeping in mind that ,this document should be useful for pharmaceutical manufacturing company who is who gmp approved and this document will provide a helpful piece of document for adhering who gmp guidelines compliance for pharmaceutical manufacturing firm, and gmp for pharmaceuticals

If I provide you a list of possible questions which a auditors are most likely going to ask and cheek ,then it will make you ready for who gmp guideline compliance , c gmp gmp for pharmaceuticals inspection any time .
What you have to do is take the copy and hand over it to respective departments and make them ready for compliance of these questions.

How to use this check list for who gmp inspection Cheke list for gmp for pharmaceuticalsCheck pervious audit report , costumers feedback's , complaints etc
And use this paper to verify the compliance for the particular point.

Following is who gmp guideline compliance ,Cheke list for gmp for pharmaceuticals ,a checklist for pharmaceutical manufacturing firm for who gmp inspection for who gmp guideline compliance
total in all there are 215 questions , including some headings.

1.0 General Controls {with respect to requirements of who gmp guide for quality assuarance } Cheke list for gmp for pharmaceuticals ,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp
Does the pharmaceutical manufacturing firm ,organizational units ,operate in a state of control as defined by the GMP regulations? who gmp guidelines are followed? Check here YES / NO

1 Organizational & Management Responsibilities for gmp. Check here YES / NO

2. Does this facility/business unit operate under a facility or corporate quality policy? Check here YES / NO

3. Does a Quality Assurance unit (department) exist as a separate organizational entity to ensuer all aspects of who gmp guide ? Check here YES / NO

4.Does the Quality Assurance unit alone have both the authority and responsibility to approve or reject all components, drug product containers and closures, in-process materials, packaging materials, labeling and drug products? Check here YES / NO

5. Does the QA department or unit routinely review production records to ensure that procedures were followed and properly documented with respect to GMP who gmp guide for quality assuarance? Check here YES / NO

6. Are adequate laboratory space, equipment, and qualified personnel available for required testing ? with respect to who gmp guide for quality assuarance Check here YES / NO

7. If any portion of testing is performed by a contractor, has the Quality Assurance unit inspected the contractor’s site and verified that the laboratory space, equipment, qualified personnel and procedures are adequate? Check here YES / NO

8. Date of last inspection:____________________
9. Are all QA procedures in writing? with respect to who gmp guidelines,who gmp guide for quality assuarance Check here YES / NO

10. Are all QA responsibilities in writing? with respect to who gmp guide for quality assuarance Check here YES / NO

11. Are all written QA procedures current and approved? (Review log of procedures) Check here YES / NO

12. Are the procedures followed? (Examine records to ensure consistent record-keeping that adequately documents testing.)Check here YES / NO

13. Are QA supervisory personnel qualified by way of training and experience with respect to who gmp guide for quality assuarance? Check here YES / NO

14. Are other QA personnel, e.g., chemists, analysts, laboratory technicians) qualified by way of training and experience with respect to who gmp guide for quality assuarance? Check here YES / NO


15. Document Control Program, with respect to who gmp guide for quality assuarance Cheke list for gmp for pharmaceuticals,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp
16. Does the QA unit have a person or department specifically charged with the responsibility of designing, revising, and obtaining approval for production and testing procedures, forms, and records ,with respect to who gmp guide for quality assuarance? Check here YES / NO

17. Does a written SOP, which identifies how the form is to be completed and who signs and countersigns, exist for each record or form ,with respect to who gmp guide for quality assuarance? Check here YES / NO

18. Is the production batch record and release test results reviewed for accuracy and completeness before a batch/lot of finished product is released ? Check here YES / NO




19. Employee Orientation, Quality Awareness, and Job Training with respect to gmp ,{with respect to requirements of who gmp guide for quality assuarance } Cheke list for gmp for pharmaceuticals,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp
20. Circle the types of orientation provided to each new employee: (1) Company brochure (2) Literature describing GMP regulations and stressing importance of following instructions. (3) On-the-job training for each function to be performed (before the employee is allowed to perform such tasks). (4) Other: enter in notebook. Check here YES / NO

21. Does each employee receive retraining on an SOP (procedures) if critical changes have been made in the procedure? Check here YES / NO

22. Indicate how on-going, periodic GMP training is accomplished. Check here YES / NO

23. is all training documented in writing that indicates the date of the training, the type of training, and the signature of both the employee and the trainer? Check here YES / NO

24. Are training records readily retrievable in a manner that enables one to determine what training an employee has received, which employees have been trained on a particular procedure, or have attended a particular training program? Check here YES / NO

25. Are GMP trainers qualified through experience and training?{with respect to requirements of who gmp guide for quality assuarance } Check here YES / NO

26. Are supervisory personnel instructed to prohibit any employee who, because of any physical condition (as determined by medical examination or supervisory observation) that may adversely affect the safety or quality of drug products, from coming into direct contact with any drug component or immediate containers for finished product? {with respect to requirements of who gmp guide for quality assuarance } Check here YES / NO

27. Are employees required to report to supervisory personnel any health or physical condition that may have an adverse effect on drug product safety and purity? Check here YES / NO

28. Are temporary employees given the same orientation as permanent employees? {with respect to requirements of who gmp guide for quality assuarance in pharmaceutical manufacturing unit }
29. Are consultants, who are hired to advise on any aspect of manufacture, processing, packing or holding, of approval for release of drug products, asked to provide evidence of their education, training, and experience? Check here YES / NO

30. Are written records maintained stating the name, address, qualifications, and date of service for any consultants and the type of service they provide? Check here YES / NO




31. Plant Safety and Security Check here {with respect to requirements of who gmp guide for quality assuarance in pharmaceutical manufacturing unit } Check list for gmp for pharmaceuticals,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp
32. Does this facility have a facility or corporate safety program? Check here YES / NO

33. Are safety procedures written? Check here YES / NO

34. Are safety procedures current? Check here YES / NO

35. Do employees receive safety orientation before working in the plant area? Check here YES / NO

36. Is safety training documented in a readily retrievable manner that states the name Check here YES / NO
of the employee, the type of training, the date of the training, and the name of the trainer and the signature of the trainer and the participant? Check here YES / NO

37. Does this facility have a formal, written security policy? Check here YES / NO

38. Is access to the facility restricted? Check here YES / NO

39. Describe how entry is monitored/restricted: Check here YES / NO

40. Is a security person available 24 hours per day? Check here YES / NO




41. Internal Quality/who gmp Audit Program /{with respect to requirements of who gmp guide for quality assuarance in pharmaceutical manufacturing unit }
Check list for gmp for pharmaceuticals,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp
42. Does this business unit/facility have a written quality policy? Check here YES / NO

43. Is a copy of this quality policy furnished to all employees? Check here YES / NO

44. If "yes" to above, when provided? __________________
45. Is training provided in quality improvement? Check here YES / NO

46. Does a formal auditing function exist in the Quality Assurance department? Check here YES / NO

47. Does a written SOP specify who shall conduct audits and qualifications (education, training, and experience) for those who conduct audits? Check here YES / NO

48. Does a written SOP specify the scope and frequency of audits and how such audits are to be documented? Check here YES / NO

49. Does a written SOP specify the distribution of the audit report? Check here YES / NO



50. Quality Cost Program for gmp cgmp Check list for gmp for pharmaceuticals,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp
{with respect to requirements of who gmp guide for quality assuarance in pharmaceutical manufacturing unit }
51. Does this facility have a periodic and formal review of the cost of quality? Check here YES / NO

52. Does this facility have the ability, through personnel, software, and accounting Check here YES / NO
records, to identify and capture quality costs? Check here YES / NO

53. Does this facility make a conscious effort to reduce quality costs? Check here YES / NO




54. Design Control with respect to who gmp cgmp Check list for gmp for pharmaceuticals,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp

Not directly related to the Drug Regulation

55. Facility Control Check here YES / NO

56. Facility Design and Layout Check here YES / NO

57. Are all parts of the facility constructed in a way that makes them suitable for the manufacture, testing, and holding of drug products? Check here YES / NO

58. Is there sufficient space in the facility for the type of work and typical volume of production? Check here YES / NO

59. Does the layout and organization of the facility prevent contamination? Check here YES / NO




60. Environmental Control Program for GMP compliance Check list for gmp for pharmaceuticals,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp
{with respect to requirements of who gmp guide for quality assuarance in pharmaceutical manufacturing unit }
61. The facility is NOT situated in a location that potentially subjects workers or product to particulate matter, fumes, or infestations? Check here YES / NO

62. Are grounds free of standing water? Check here YES / NO

63. Is lighting adequate in all areas? Check here YES / NO

64. Is adequate ventilation provided? Check here YES / NO

65. Is control of air pressure, dust, humidity and temperature adequate for the manufacture, processing, storage or testing of drug products? Check here YES / NO

66. If air filters are used, is there a written procedure specifying the frequency of inspection and replacement? Check here YES / NO

67. Are drains and routine cleaning procedures sufficient to prevent standing water inside the facility? Check here YES / NO

68. Does the facility have separate air handling systems, if required, to prevent contamination? (MANDATORY IF PENICILLIN IS PRESENT!) Check here YES / NO




69. Facility Maintenance and Good Housekeeping Program for GMP with respect to who gmp guide for quality assuarance Check list for gmp for pharmaceuticals,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp
70.Is this facility free from infestation by rodents, birds, insects and vermin? Check here YES / NO

71. Does this facility have written procedures for the safe use of suitable, (e.g. those that are properly registered) rodenticides, insecticides, fungicides, and fumigating agents? Check here YES / NO

72. Is this facility maintained in a clean and sanitary condition? Check here YES / NO

73. Does this facility have written procedures that describe in sufficient detail the cleaning schedule, methods, equipment and material? with respect to who gmp guide for quality assuarance
74. Does this facility have written procedures for the safe and correct use of cleaning and sanitizing agents? with respect to who gmp guide for quality assuarance, Check here YES / NO

75. Are all parts of the facility maintained in a good state of repair ?
76. Is sewage, trash and other refuse disposed of in a safe and sanitary manner (and with sufficient frequency?) Check here YES / NO




77. Outside Contractor Control Program {with respect to requirements of who gmp guide for quality assuarance in pharmaceutical manufacturing unit } Check list for gmp for pharmaceuticals,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp
78. Are contractors and temporary employees required to perform their work under sanitary conditions? with respect to who gmp guide for quality assuarance. Check here YES / NO

79. Are contractors qualified by experience or training to perform tasks that may influence the production, packaging, or holding of drug products? Check here YES / NO




80 Equipment Control with respect to who gmp cgmp Check list for gmp for pharmaceuticals,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp
81 Equipment Design and Placement Check here YES / NO

82 Is all equipment used to manufacture, process or hold a drug product of appropriate design and size for its intended use? Check here YES / NO

83. Are the following pieces of equipment suitable for their purpose? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). Check here YES / NO

84. Are the following pieces of equipment suitable in their size/capacity? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). Check here YES / NO

85. Are the following pieces of equipment suitable in their design? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). Check here YES / NO

86. Are the locations in the facility of the following pieces of equipment acceptable? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). Check here YES / NO

87. Are the following pieces of equipment properly installed? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). Check here YES / NO

88. Is there adequate space for the following pieces of equipment? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify),for GMP Check here YES / NO

89. Are machine surfaces that contact materials or finished goods non-reactive, non-absorptive, and non-additive so as not to affect the product? Check here YES / NO

90. Are design and operating precautions taken to ensure that lubricants or coolants or other operating substances do NOT come into contact with drug components or finished product? Check here YES / NO

91. Fiber-releasing filters are NOT used in the production of injectable products? Check here YES / NO

92. Asbestos filters are NOT used in the production of products, with respect to who gmp guide for quality assuarance? YES / NO
93. Is each idle piece of equipment clearly marked "needs cleaning" or "cleaned; ready for service"? Check here YES / NO

94. Is equipment cleaned promptly after use? YES / NO Check here YES / NO

95. Is idle equipment stored in a designated area? Check here YES / NO

96. Are written procedures available for each piece of equipment used in the manufacturing, processing or holding of components, in-process material or finished product? Check here YES / NO

97. Do cleaning instructions include disassembly and drainage procedure, if required, to ensure that no cleaning solution or rinse remains in the equipment? Check here YES / NO

98. Does the cleaning procedure or startup procedure ensure that the equipment is systematically and thoroughly cleaned? Check here YES / NO




99. Equipment Identification with respect to gmp Check list for gmp for pharmaceuticals,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp
100. Are all pieces of equipment clearly identified with easily visible markings? Check here YES / NO

101. Are all pieces of equipment also marked with an identification number that corresponds with an entry in an equipment log? Check here YES / NO

102. Does each piece of equipment have written instructions for maintenance that includes a schedule for maintenance? Check here YES / NO

103. Is the maintenance log for each piece of equipment kept on or near the equipment? Check here YES / NO




104.Equipment Maintenance & Cleaning with respect to gmp Check list for gmp for pharmaceuticals,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp
105. Are written procedures established for the cleaning and maintenance of equipment and utensils? Check here YES / NO

106. Are these procedures followed? Check here YES / NO

107. Does a written procedure assign responsibility for the cleaning and maintenance of equipment? Check here YES / NO

108. Has a written schedule been established and is it followed for the maintenance and cleaning of equipment? Check here YES / NO

109. Has the cleaning procedure been properly validated? with respect to who gmp guide for quality assuarance .Check here YES / NO

110. If appropriate, is the equipment sanitized using a procedure written for this task? Check here YES / NO

111. Has a sufficiently detailed cleaning and maintenance procedure been written for each different piece of equipment to identify any necessary disassembly and reassembly required to provide cleaning and maintenance? Check here YES / NO

112. Does the procedure specify the removal or obliteration of production batch information from each piece of equipment during its cleaning?
113. Is equipment cleaned promptly after use? IS GMP FOLLOWED Check here YES / NO

114. Is clean equipment clearly identified as "clean" with a cleaning date shown on the equipment? Check here YES / NO

115. Is clean equipment adequately protected against contamination prior to use? Check here YES / NO

116. Is equipment inspected immediately prior to use? Check here YES / NO

117. Are written records maintained on equipment cleaning, sanitizing and maintenance on or near each piece of equipment? Check here YES / NO




118. Measurement Equipment Calibration Program for gmp cgmp {with respect to requirements of who gmp guide for quality assuarance in pharmaceutical manufacturing unit } Check list for gmp for pharmaceuticals,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp

119. Does the facility have approved written procedures for checking and calibration of each piece of measurement equipment? (Verify procedure and log for each piece of equipment and note exceptions in notebook with cross reference.) Check here YES / NO

120. Are records of calibration checks and inspections maintained in a readily retrievable manner? Check here YES / NO




121. Equipment Qualification Program for gmp {with respect to requirements of who gmp guide for quality assuarance in pharmaceutical manufacturing unit } Check list for gmp for pharmaceuticals,pharmaceuticals manufacturers guide for gmp
122. Verify that all pieces of equipment used in production, packaging, and quality assurance are capable of producing valid results. Check here YES / NO

123. When computers are used to automate production or quality testing, have the computer and software been validated? Check here YES / NO

124. Have on-site tests of successive production runs or tests been used to qualify equipment? Check here YES / NO

125. Were tests repeated a sufficient number of times to ensure reliable results? Check here YES / NO

126. Is each piece of equipment identified to its minimum and maximum capacities and minimum and maximum operating speeds for valid results? Check here YES / NO

127. Have performance characteristics been identified for each piece of equipment? (May be provided by the manufacturer, but must be verified under typical operations conditions.) Check here YES / NO

128. Have operating limits and tolerances for performance been established from performance characteristics? Check here YES / NO




Material/Component Control {with respect to requirements of who gmp guide for quality assuarance in pharmaceutical manufacturing unit }Check list for gmp for pharmaceuticals,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp
129. Material/Component Specification and Purchasing Control
Although purchasing is not specifically addressed in the current GMP regulation, incumbent upon user of components and materials to ensure quality of product, material or component. Check here YES / NO

130. Has each supplier/vendor of material or component been inspected/audited for proper manufacturing controls? (Review suppliers and audits and enter names, material supplied, and date last audited in notebook.) Check here YES / NO




131.Material/Component Receipt, Inspection, Sampling, and Laboratory Testing Check here YES / NO

132. Does the facility have current written procedures for acceptance/rejections of drug products, containers, closures, labeling and packaging materials? (List selected materials and components in notebook and verify procedures.) Check here YES / NO

133. Is each lot within each shipment of material or components assigned a distinctive code so material or component can be traced through manufacturing and distribution? Check here YES / NO

134. Does inspection start with visual examination of each shipping container for appropriate labeling, signs of damage, or contamination? Check here YES / NO

135. Is the number of representative samples taken from a container or lot based on statistical criteria and experience with each type of material or component?
136. Is the sampling technique written and followed for each type of sample collected? Check here YES / NO

137. Is the quantity of sample collected sufficient for analysis and reserve in case retesting or verification is required? Check here YES / NO

Verify that the following steps are included in written procedures unless more specific procedures are followed:
138. Containers are cleaned before samples are removed. Check here YES / NO

139. Stratified samples are not composited for analysis. Check here YES / NO

140. Containers from which samples have been taken are so marked indicating date and approximate amount taken. Check here YES / NO
141. Each sample container is clearly identified by material or component name, lot number, date sample taken, name of person taking sample, and original container identification. Check here YES / NO

142. At least one test is conducted to confirm the identity of a raw material (bulk chemical or pharmaceutical) when a Certificate of Analysis is provided by supplier and accepted by QA. Check here YES / NO

143. If a Certificate of Analysis is not accepted for a lot of material, then additional testing is conducted by a written protocol to determine suitability for purpose.
144. Microbiological testing is conducted where appropriate. Check here YES / NO



145. Material Component Storage and Handling with respect to GMPcGMP Check list for gmp for pharmaceuticals,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp
(Verify that materials and components are stored and handled in a way that prevents contamination, mixups, and errors.)
146. Are incoming material and components quarantined until approved for use? Check here YES / NO

147. Are all materials handled in such a way to prevent contamination? Check here YES / NO

148. Are all materials stored off the floor? Check here YES / NO

149. Are materials spaced to allow for cleaning and inspection? Check here YES / NO

150. Are labels for different products, strengths, dosage forms, etc., stored separately with suitable identification? Check here YES / NO

151. Is label storage area limited to authorized personnel? Check here YES / NO

152. Are rejected components, material, and containers quarantined and clearly marked to prevent their use? Check here YES / NO




153. Inventory Control Program for GMP {with respect to requirements of who gmp guide for quality assuarance in pharmaceutical manufacturing unit } Check list for gmp for pharmaceuticals,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp

154. Are inventory control procedures written? Check here YES / NO

155. Does the program identify destruction dates for obsolete or out-dated materials, components, and packaging materials? Check here YES / NO

156. Is stock rotated to ensure that the oldest approved product or material is used first? Check here YES / NO

157. Is destruction of materials documented in a way that clearly identifies the material destroyed and the date on which destruction took place? Check here YES / NO




Vendor (Supplier) Control Program {with respect to requirements of who gmp guide for quality assuarance in pharmaceutical manufacturing unit } Check list for gmp for pharmaceuticals,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp
158. Are vendors periodically inspected according to a written procedure? Check here YES / NO

159. Is the procedure for confirming vendor test results written and followed? Check here YES / NO




Operational Control {with respect to requirements of who gmp guide for quality assuarance in pharmaceutical manufacturing unit } Check list for gmp for pharmaceuticals,pharmaceuticals manufacturers guide for gmp
160. Material/Component/Label Verification, Storage, and Handling Check here YES / NO

161. Do written procedures identify storage time beyond which components, containers, and closures must be reexamined before use? Check here YES / NO

161. Is release of retested material clearly identified for use? Check here YES / NO

162. Are retesting information supplements originally obtained? Check here YES / NO

163. Do written procedures identify steps in the dispensing of material for production? Check here YES / NO

164. Do these procedures include (1) release by QC, (2)Documentation of correct weight or measure, and (3) Proper identification of containers? Check here YES / NO

165. Does a second person observe weighing/measuring/dispensing and verify accuracy with a second signature? Check here YES / NO

166. Is the addition of each component documented by the person adding the material during manufacturing? Check here YES / NO

167. Does a second person observe each addition of material and document verification with a second signature? Check here YES / NO

168. Does a written procedure specify who is authorized to issue labels? Check here YES / NO

169. Does a written procedure specify how labels are issued, used, reconciled with production, returned when unused, and the specific steps for evaluation of any discrepancies? Check here YES / NO

170. Do written procedures call for destruction of excess labeling on which lot or control numbers have been stamped or imprinted? Check here YES / NO




171.Equipment/Line/Area Cleaning, Preparation, and Clearance
172. Do written procedures detail how equipment is to be checked immediately prior to use for cleanliness, removal of any labels and labeling from prior print operations? Check here YES / NO

173. Do written procedures detail any disconnection and reassembly required to verify readiness for use?



174.Operational Process Validation and Production Change Order Control,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp
{with respect to requirements of who gmp guide for quality assuarance in pharmaceutical manufacturing unit } Check list for gmp for pharmaceuticals
175. Have production procedures been validated? (Review selected procedures for validation documentation. Adequate?) Check here YES / NO

176. Does the process control address all issues to ensure identity, strength, quality and purity of product? Check here YES / NO

177. Does the procedure include formulation that is written to yield not less than 100% of established amount of active ingredients? Check here YES / NO

178. Are all weighing and measuring preformed by one qualified person and observed by a second person? Check here YES / NO

179. Have records indicated preceding policy been followed by presence of two signatures? Check here YES / NO

180. Are actual yields calculated at the conclusion of appropriate phases of the operation and at the end of the process? Check here YES / NO

181. Are calculations performed by one person? Is there independent verification by a second person? Check here YES / NO




In-Process Inspection, Sampling, and Laboratory Control {with respect to requirements of who gmp guide for quality assuarance in pharmaceutical manufacturing unit } Check list for gmp for pharmaceuticals,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp

182. Are written procedures established to monitor output and validate the performance of manufacturing procedures that may cause variability in characteristics of in-process materials and finished drug products? Check here YES / NO

183. Are in-process materials tested at appropriate phases for identity, strength, quality, purity and are they approved or rejected by Quality Control? Check here YES / NO

184. Are there laboratory controls including sampling and testing procedures to assure conformance of components, containers, closures, in-process materials, and finished product specifications? Check here YES / NO




185. Reprocessing/Disposition of Materials Check here YES / NO

186. Do written procedures identify steps for reprocessing batches? Check here YES / NO

187. Are quality control review and approval required for any and all reprocessing of material? Check here YES / NO

188. Does testing confirm that reprocessed batches conform to established specification? Check here YES / NO

189. Does a written procedure outline steps required to reprocess returned drug products (if it can be determined that such products have not been subjected to improper storage conditions?) Check here YES / NO

190. Does Quality Control review such reprocessed returned goods and test such material for conformance to specifications before releasing such material for resale?
Check here YES / NO



Finished Product Control {with respect to requirements of who gmp guide for quality assuarance in pharmaceuticals manufacturing company} Check list for gmp for pharmaceuticals,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp

191. Finished Product Verification, Storage, and Handling Check here YES / NO

192. Do written procedures indicate how and who verifies that correct containers and packages are used for finished product during the finishing operation? Check here YES / NO

193. In addition, do written procedures require that representative sample of units be visually examined upon completion of packaging to verify correct labeling? Check here YES / NO

195. Are expiration dates stamped or imprinted on labels? Check here YES / NO

196. Are expiration dates related to any storage conditions stated on the label? Check here YES / NO

197. Are all finished products held in quarantine until QC has completed its testing and releases product on a batch to batch basis for sale? Check here YES / NO

198. Is finished product stored under appropriate conditions of temperature, humidity, light, etc. Check here YES / NO




199. Finished Product Inspection, Sampling, Testing, and Release for Distribution
200. Has the formulation for each product been tested for stability based on a written protocol? (Containers must duplicate those used in final product packaging.) Check here YES / NO

201. Are written sampling and testing procedures and acceptance criteria available for each product to ensure conformance to finished product specifications? Check here YES / NO

202. Is a quantity of samples equal to at least twice the quantity needed for finished product release testing maintained as a reserve sample? Check here YES / NO

203. Are sterility and pyrogen testing performed as required? Check here YES / NO

204. Are specific tests for foreign particles or abrasives included for any ophthalmic ointments? Check here YES / NO

205. Do controlled release or sustained release products include tests to determine conformance to release time specification? Check here YES / NO




Distribution Controls {with respect to requirements of who gmp guide for quality assuarance in pharmaceuticals manufacturing company} Check list for gmp for pharmaceuticals,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp
206. Does a written procedure manage stocks to ensure that oldest approved product is sold first? Check here YES / NO

207. Are deviations to the policy above documented? Check here YES / NO

208. Does a written procedure identify the steps required if a product recall is necessary? Check here YES / NO

209. Is the recall policy current and adequate? Check here YES / NO




Marketing Controls {with respect to requirements of who gmp guide for quality assuarance in pharmaceuticals manufacturing company} Check list for gmp for pharmaceuticals,pharmaceuticals manufacturers guide for gmp
210. The current regulation does not address marketing controls per se except that all finished products must meet their specifications. Check here YES / NO




Complaint Handling and Customer Satisfaction Program , {with respect to requirements of who gmp guide for quality assuarance in pharmaceuticals manufacturing company} Check list for gmp for pharmaceuticals,guide for pharmaceutical validations,pharmaceuticals manufacturers guide for gmp

11.Are complaints, whether received in oral or written form, documented in writing and retained in a designated file? Check here YES / NO

212. Are complaints reviewed on a timely basis by the Quality Control Unit? Check here YES / NO

213. Is the action taken in response to each complaint documented? Check here YES / NO

214. Are decisions not to investigate a complaint also documented and the name of the responsible person documented? Check here YES / NO

215. Are complaint investigations documented and do they include investigation steps, findings, and follow-up steps, if required? Are dates included for each entry? Check here YES / NO

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More over if you want futher information on GMP guidelines you can search over this blog.
there is complete and very good information about gmp for pharmaceuticals ,water system validation,gmp master formula ,validation guidelines to pharmaceuticals dosage form ,cleaning validation sop ,guideline for terminally sterilized products,pharmaceutical manufacturing change control ,i have given here a sample change control document and pharmaceuticals manufacturing, sop, stability documents .clean room validations , aseptic area and their requirement regarding environmental controll,guide for pharmaceutical validations.pharmaceuticals manufacturers guide for gmp
Quality assuarance guide for pharmaceuticals manufacturing
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Guide for pharmaceuticals manufacturing

ALL MOST ALL INFORMATION ABOUT QUALITY ASSUARANCE FOR GMP PHARMACEUTICALS DOCUMENTAION OVER THIS WEBSITE IS AVAILABLE ,WHAT YOU NEED TO DO IS SEARCH OVER THIS BLOG OVER BLOG ARCHIVE OF THIS BLOG.
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3 comments:

Dr. Davon Jacobson, MD said...

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DADASAHEB said...

This is an excellent information for all of those Quality Inspectors preparing to face WHO audit and Or trying to implement as well maintain the standards of WHO.
I am glad and hopefull that your site will be long lived on net.

Imtiaz Ibne Alam said...

Thank you for such needed post. I just loved to read it. However, I want to know that is this post updated to present WHO updates.

Posted by: Martin

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