SOP on Manufacturing Operations and Controls

Manufacturing Operations and Controls

  • All manufacturing operations shall be carried out under the supervision of technical staff approved by the Licensing Authority.
  • Each critical step in the process relating to the selection, weighing, and measuring of raw material addition during various stages shall be performed by trained personnel under the direct personal supervision of approved technical staff.
    The contents of all vessels and containers used in manufacture and storage during the various manufacturing stages shall be conspicuously labeled with the name of the product, batch no., batch size and stage of manufacture.
  • Each label should be initialed and dated by the authorized technical staff.
    Products not prepared under aseptic conditions are required to be free from pathogens like Salmonella, Escherichia coli, Pyocyanea etc.

Precautions against mix–up and cross-contamination –

  • The licensee shall prevent mix-up and cross-contamination of drug material and drug product (from environmental dust) by the proper air-handling system, pressure differential, segregation, status labeling, and cleaning.
  • Proper records and Standard Operating Procedures thereof shall be maintained.
  • The licensee shall ensure the processing of sensitive drugs like Beta-Lactum antibiotics, sex hormones, and cytotoxic substances in segregated areas or isolated production areas within the building with an independent air-handling unit and proper pressure differentials.
  • The effective segregation of these areas shall be validated with adequate records of maintenance and services.
  • To prevent mix-ups during production stages, the material under- process shall be conspicuously labeled to demonstrate their status. All equipment used for production shall be labeled with its current status.
  • Packaging lines shall be independent and adequately segregated. It shall be ensured that all left-overs of the previous packaging operations, including labels, cartons, and caps are cleared before the closing hour.
  • Before packaging operations are begun, steps shall be taken to ensure that the work area, packaging lines, printing machines, and other equipment are clean and free from any products, materials, and spillages. The line clearance shall be performed according to an appropriate checklist and recorded.
  •  The correct details of any printing (for example batch numbers or expiry dates) done separately or in the course of the packaging shall be re-checked at regular intervals. All printing and over-printing shall be authorized in writing.
  • The manufacturing environment shall be maintained at the required levels of temperature, humidity, and cleanliness.
  • Authorized persons shall ensure change-over into specific uniforms before undertaking any manufacturing operations including packaging.
  • There shall be segregated secured areas for recalled or rejected material and for such material which are to be re-processed or recovered.


About Abha Maurya

Abha is the Author of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in the pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, and Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008, and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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