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Master document is a formally authorized source document relating to specifications, and / or manufacturing / analytical methods, which is protected from un-authorized access or amendment.
** Documents required describing the quality system requirements in the organization.
** Documents required describing the process or product characteristics.
** Documents required by various regulatory agencies as part of compliance to GMP requirements.
** Documents required for legal/ regulatory supports of the organization to meet the local regulations.
** Any other documents required by government / regulatory agency.
