- Preparation, Approval and Control of Standard Cleaning Procedures for equipments
- OBJECTIVE :
- To lay down the guidelines for the preparation, approval and control of Standard Cleaning Procedure (SCP) for all the applicable equipments.
- RESPONSIBILITY :
- All the personnel involved in the cleaning of equipments.
- Heads of concerned departments to ensure compliance.
- PROCEDURE
- Every equipment shall be cleaned and certified as per the respective Standard Cleaning Procedure (SCP) as applicable for that particular equipment.
- Every SCP shall be validated as per the requirement.
- Different cleaning procedures shall be followed depending upon the equipment status i.e., whether the cleaning is between batches of same product or between batches of product containing same drug substance but of different strengths or different product (product changeover) etc., for all the process equipment’s.
- Based on the above consideration three types of cleaning procedures have been described, for process equipment’s, viz.
- Type A Cleaning Procedure (Vacuuming and dry wiping)
- Type B Cleaning Procedure (Vacuuming and washing with potable water followed by purified water unless otherwise specified in the respective SCP)
- Type C Cleaning Procedure (Washing with detergent solution then potable water, then Purified water and finally with purified water unless otherwise specified in the respective SCP).
- The decision about the type of cleaning to be carried out for all the process equipments i.e., whether Type A, Type B or Type C can be made with the help of ‘Standard Cleaning Procedure Type Selection Guide’ Annexure-1.
- All the cleaning details shall be entered in the Equipment Usage and Cleaning Logbook (Annexure-4) as applicable.
- SCPs are to be generated by computer on the format known as ‘Standard Cleaning Procedure’ (annexure-2). Guidelines for filling the format are asdescribed below.
- SCP No :
- This is a unique number given to each SCP. This number consists of nine characters as described below:
- The first character is ‘C’ which denotes cleaning.
- The next two characters are alphabets denoting department code as given below.
- Department Code
- Production – PD
- Quality Control – QC
- Analytical R&D – AD
- Quality Assurance – QA
- Warehouse – WH
- The next three characters denote serial number in the sequential order starting from 001 in each department.
- The seventh character is ” – ” (dash)
- The last two characters denote revision number. The first time any SCP is written, it shall be numbered as “00”. The first revised SCP shall be “01” and so on.
- Example : The first SCP prepared for Production Department shall be numbered as “CPD001-00” and the first revision of the same shall be “CPD001-01”.
- Page No. :
- Give the specific page number as well as the total pages comprising the SCP. Example : 1 of 5.
- Department :
- Give the name of the Department to which the SCP pertains.
- Example : Research & Development.
- Title :
- Give the detailed heading of the SCP.
- Effective Date :
- Give the date when the SCP becomes operative after training the concerned personnel.
- Date shall be written as follows
- DD – MM – YY
- (Date) (Month) (Year) Example : 20 – 01 – 17
- Initiated by :
- The person who prepares the SCP, shall sign with date in this column. The operating personnel of the respective department shall prepare the SCP.
- Approved by :
- Each SCP shall be approved by the Head of the operating department and Head of QA Department or their respective designees. The approving authority shall ensure that the SCP is duly validated, wherever applicable.
- Authorised by :
- The SCP shall be authorised for implementation by the Divisional Head.
- Each SCP shall have the following headings :
- Objective 2. Responsibility 3. Procedure 4. Documentation
- Objective :
- An overview of the intent of the SCP shall be briefly mentioned here.
- Responsibility :
- Shall specify the personnel responsible for the implementation and compliance.
- Procedure :
- Shall describe the detailed cleaning procedure in simple and clear sentences.
- Documentation :
- Shall include appropriate formats, labels etc., needed to record the compliance with SCP.
- Each format shall be given a number. The number consists of 13 characters.
- The first character is ‘C’ denotes cleaning.
- The next two characters are alphabets denoting department code
- The next three characters denote serial number of the SCP.
- The seventh character is “-” dash.
- The eighth character is ‘F’ denote “Format”.
- The ninth and tenth characters denote the serial number of the format of the particular SCP.
- The eleventh character is “-” dash.
- The last two characters denote Revision.
- Format No. shall appear on left bottom of the format.
- A specimen of each format shall be enclosed with respective SCP and stamped as “Specimen” and signed by Head of Quality Assurance Department or his designee.
- Submission of New SCP :
- The initiator of the SCP shall prepare a draft copy of the proposed SCP based on the above guidelines and forward it to the Department Head for approval.
- Once approved by the Department Head, the same shall be routed for approval to the Head of Quality Assurance and the Divisional Head.
- A disagreement on any aspect of the SCP from any one of the approvers shall stop any ‘New SCP submission’ until all approvers agree on the proposed new SCP. The Original Copy shall be initiated, approved and authorised with signature and date. The effective date shall be entered after training the concerned personnel on the new SCP.
- Revision of SCP : Any changes desired and deemed necessary, shall be initiated through a ‘Change Request ‘ (annexure-5) as per SOP on ‘Change Control’.
- Whenever SCP is revised, the changes made shall be enetered on the ‘ChangeHistory’ (annexure-6) and attached at the end of the SCP.
- Distribution and Control of SCP :
- The original copy of the SCP shall have the original signatures and shall be maintained at Documentation cell.
- Issue of SCP shall be controlled by QA department. The details of issuance shall be entered in “Issue record” (annexure -3).
- Officer – Documentation shall provide the photocopy of the SCPs from the original copy to the concerned department(s).
- Officer – Documentation shall stamp “Issued by : ____________”
- ”Issued to : ____________”
- “User Copy No.: ____________”
- on the top of the SCP, sign with date and issue the copy to the concerned Department/Section/Area.
- The details of issuance shall be entered in “Issue Record” .
- Photocopying of any SCP shall be prohibited, unless written permission is obtained from the Head of Quality Assurance department.
- If need arises for an additional copy of SCP, the concerned Head of the Department shall make request with justification to Head -Quality Assurance.
- Head – QA shall arrange for the issue of copy of the requested SCP.
- Any SCP issued for non-operational use shall be stamped as ‘Uncontrolled Copy, Not for Operational Use’ on every page, with signature of Head of Quality Assurance Department or his designee.
- User copies of old and superseded SCPs shall be returned to QA department. Head – QA shall ensure reconciliation and destruction. The destruction details shall be entered in “Issue Record” . The Original copy shall be stamped as “Obsolete – For reference only” and stored.
- Forms and Records (Annexures)
- Specimen format of “Standard Cleaning Procedure”- Annexure – 2
- Specimen format of “Issue Record” – Annexure-3.
- Specimen formats of “Equipment Usage and Cleaning Log” – Annexure-4.
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
- History
Date Revision Number Reason for Revision – 00 New SOP
Annexure-2.
|
STANDARD CLEANING PROCEDURE TYPE SELECTION GUIDE |
||||
| S No. | Active* | Inactive* | Proportion* | Type |
| 1. | Same | Same | Same | A |
| 2. | Same | Same | Different (of inactives) | A |
| 3. | Same (LS to HS) | Same | Same (dose proportional) | A |
| 4. | Same (HS to LS) | Same | Same (dose proportional) | A |
| 5. | Same (LS to HS) | Same | Different (of inactives) | A |
| 6. | Same(HS to LS) | Same | Different(of inactives) | B |
| 7. | Different | Same/ Different | Same/ Different | C |
| 8. | Same | Different | NA | B |
| 9. | Same | Different/ Same | Color different | C |
| Note : After 6 days of Type A cleaning, Type C cleaning shall be carried out) | ||||
| * With respect to previous batch processed in the equipment. | ||||
| LS – Low strength | ||||
| HS – High strength | ||||
|
1. |
Type ‘B’ cleaning shall be performed at the end of day’s operation. |
| 2. | Sifter after 14 days or after 20 batches whichever is earlier. |
| 3. | Compression after 14 days or after 20 batches
whichever is earlier. |
| 4. | Coating after 6 days or after 12 batches whichever is earlier. |
| 5. | Capsule filling machine after 12 days or after 20 batches whichever is earlier. |
| 6. | Blister packing machine / Swift pack after 14 days or after 20 batches
whichever is earlier. |
Annexure-3.
Specimen format of “Issue Record”
| SCP NO. | ISSUE | RETURN | ||||||
| User Copy No. | Location | Issued by | Received by | Returned by | Destroyed by | Destroyed on | ||
Annexure-4
Specimen formats of “Equipment Usage and Cleaning Log”
| PHARMA DIVISION | Equipment Name : _____________________________________________________________ | ||||||||||
| PRODUCTION/PILOT PRODUCTION | Equipment No. : _____________________________________________________________ | ||||||||||
| S No. | Date | Time | Previous Product | Batch No./ | SCP No. | Type of | Equipment | Equipment cleaning checked by | Remarks | ||
| Lot No. | cleaning | cleaned by | Production officer | QA Officer | |||||||
