{"id":264,"date":"2021-05-14T06:54:06","date_gmt":"2021-05-14T06:54:06","guid":{"rendered":"http:\/\/tech3.mypagedemo.com\/cm-plus\/?page_id=264"},"modified":"2021-06-25T09:12:41","modified_gmt":"2021-06-25T09:12:41","slug":"pharmaceutical","status":"publish","type":"page","link":"https:\/\/tech3.mypagedemo.com\/cm-plus\/business-fields\/pharmaceutical","title":{"rendered":"Pharmaceutical"},"content":{"rendered":"

[vc_row animation_type=”fadeIn”][vc_column width=”1\/4″][\/vc_column][vc_column width=”1\/2″][vc_empty_space height=”20px”][vc_custom_heading text=”Pharmaceutical” font_container=”tag:h2|text_align:center|color:%23dd3333″ use_theme_fonts=”yes”][\/vc_column][vc_column width=”1\/4″][\/vc_column][\/vc_row][vc_row animation_type=”fadeIn”][vc_column width=”1\/4″][\/vc_column][vc_column width=”1\/2″][vc_btn title=”GMP Consulting” style=”3d” color=”danger” size=”xl” align=”center”][\/vc_column][vc_column width=”1\/4″][\/vc_column][\/vc_row][vc_row el_id=”gmp”][vc_column][vc_column_text]We deliver professional services to provide best valued solutions to any questions that clients may have in relation to all international GMP standards such as EU-GMP (PIC\/S), cGMP, J-GMP and WHO-GMP.<\/strong>[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=”cmplus-tabs” animation_type=”fadeInUp”][vc_column width=”1\/4″][vc_custom_heading text=”1. From Gap Analysis to Mock Inspection” font_container=”tag:h4|text_align:center” use_theme_fonts=”yes”][vc_single_image image=”516″ img_size=”full” alignment=”center”][\/vc_column][vc_column width=”3\/4″][vc_column_text]At the First step, if a new GMP like PIC\/S GMP should be additionally applied to a factory in operation, the Man, Machine, Method and Material must be investigated to identify gaps or differences from the relevant GMP requirements.<\/p>\n

CM Plus will investigate and analyze the gaps, and report to the client with a clear proposal on possible countermeasures and a road map for subsequent actions.<\/p>\n

At the Second, a further detailed discussion should be taken place to determine the way to go. In order to facilitate such discussions, CM Plus usually categorizes the gaps into two groups, namely \u201chardware\u201d and \u201csoftware\u201d, and proceeds with discussions with the client to come up with best valued solutions in favor of the client.<\/p>\n

At the Third, according to client\u2019s request, CM Plus will assume responsibilities for execution of engineering and construction. CM Plus will also provide the client with professional support
\nservices to set up proper quality systems with pertinent standard operation procedures (SOP)
\nand GMP training courses for the personnel.<\/p>\n

At last, CM Plus will perform a mock inspection to assure that all of the 4-Ms (Man, Machine,
\nMethod and Material) should be made good for expected inspections by the competent authority.[\/vc_column_text][vc_btn title=”More” style=”modern” el_class=”btn_toggle”][\/vc_column][\/vc_row][vc_row][vc_column][vc_separator color=”juicy_pink”][\/vc_column][\/vc_row][vc_row animation_type=”fadeInUp”][vc_column width=”1\/4″][vc_custom_heading text=”2. Support to build and improve Quality Management System (QMS\/PQS)” font_container=”tag:h4|text_align:center” use_theme_fonts=”yes”][vc_single_image image=”522″ img_size=”full” alignment=”center”][\/vc_column][vc_column width=”3\/4″][vc_column_text]Our consultants can help clients build and reorganize quality management systems (QMS) and
\npharmaceutical quality systems (PQS).
\nThey can also propose an ideal SOP documentation structure based on sound quality assurance policies.
\nThe service also covers documentation support, including Master Batch Records (MBRs) for making reliable and efficient release, and SOPs and other records for assuring high quality manufacturing operations.
\nOutput:
\n– GMP organization,
\n– QMS\/PQS documentation management structures
\n– MBRs (for manufacturing\/packaging), SOPs.[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_separator color=”juicy_pink”][\/vc_column][\/vc_row][vc_row animation_type=”fadeInUp”][vc_column width=”1\/4″][vc_custom_heading text=”3. Support to build and improve Laboratory Control System” font_container=”tag:h4|text_align:center” use_theme_fonts=”yes”][vc_single_image image=”174″ img_size=”full” alignment=”center”][\/vc_column][vc_column width=”3\/4″][vc_column_text]The service covers support for building a wide range of quality assurance systems, including management of samples\/reference standards\/reagents, validation of analytical methods, and qualification\/ maintenance\/calibration of test equipment.
\nOutput:<\/p>\n