SOP on handling of rinse and swab sample

SOP on handling of rinse and swab sample

Objective:

  • To lay down the procedure for handling of rinse and swab sample.

Scope:

  • This procedure is applicable for handling of rinse and swab sample in QC Department

Responsibility:

  • Chemist or above of QC department
  • Executive / nominee of QC department

Accountability:

  • Head – Quality Control department

Procedure:

swab sample

  • In-process Quality Assurance personnel shall collect the sample of rinse or swab sample and handover the sample to QC department along with sample intimation slip as per annexure No. A03 filled with all details.
  • Quality Control chemist or above shall record information of rinse and swab sample in rinse and swab sample inward register as per Annexure No. A01
  • AR No. of rinse and swab sample shall be generated as per SOP .
  • Quality Control Executive / Nominee shall allocate the sample to chemist for analysis.
  • Quality Control Chemist shall perform the analysis as per standard test procedure of respective product, and record the raw data in continuation sheet.
  • After completion of analysis, Executive / Nominee shall review the results and shall send to Head QC for final approval.
  • After approval from QC Head one signed copy of rinse and swab intimation slip shall be send to IPQA section.
  • If results are found out of specification, then (SOP on handling investigation and reporting of out of specification results) shall be followed for necessary action.

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List of Annexure / Formats:

Sr.

No.

Format TitleAnnexure

Number

1Rinse and swab Sample Inward RegisterA01

References (if any).

Reason for Revision.

  • Not Applicable due to new SOP.

Abbreviations:

  •  SOP  :  Standard Operating Procedure
  • QC   :  Quality Control
  • SG  :  Sub – General
  • SP  :  Specific
  • QA  :  Quality Assurance
  •  IPQA   : In-process Quality Assurance
  • AR.No. : Analytical Reference Number

Annexure 1

Rinse and swab Sample Inward Register

Sr.

No.

Date

Type of sample

(Rinse / swab)

Name of

Equipment

Name of

previous product

Previous product

batch No.

Equipment

to be used for

Sampled By

     A.R.

No.

Date of analysis

Analysed By

Status

Remarks

 

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About Alice

Alice is the Author and founder of Drugsformulations, she is a pharmaceutical professional having more than 18 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, and Nectar life Science 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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