Saturday, 14 May 2022

Internal Audit Checklist Template | Word Format

Internal Audit Checklist Template for Engineering Department:

Internal Audit Checklist Template word file


Preventive Maintenance / Calibration schedule is available and completed as per SOP

All equipment is properly maintained and records of this maintenance area kept.  In addition, equipment is inspected for serviceability before any operation begins.

Current Master Calibration schedule available for all instruments.

Inventory management of engineering spares done as per SOP and records maintained.

Training and evaluation of all relevant procedure is complete.

Break down maintenance I preventive maintenance entries in log book is complete

All related drawing are approved & updated

Training documentation and Accountability statement being maintained

Data Integrity |Internal Audit Checklist Template

Are all entries in clear, legible, visible and readable handwriting?

Is the data being integer, complete & consistent?

Is the data entering by mistake?

Is data true and signed copy?

In case of any correction, cross out the information with single line so that original entries are seen?

Are all the entries made by the person who executed the task?  

Is any lines or columns found without entry?

Is corrective action taken to avoid data integrity & wrong entries?

HVAC

Air changes, particle count. Air velocity, monitoring done as per SOP.

Monitoring room conditions in production area, controlled storage area done as per SOP and records are maintained

All SOPs are available and followed

Reports of cooling/ chilled water are available from outside agency.

Storage area print -outs checking

Usage log book are available and complete

Pipe line color, coding 'and direction of flow as per

SOP

Coding of various HVAC filters are done as per sop

Major maintenance reports are completed are made and records are complete.

Calibration of gauges / timers /   Digital thermometers I measuring instruments done as per schedule and records are maintained

Calibration failures, if any, are investigated

Wednesday, 10 November 2021

MICROBIAL COUNT OF SURFACE CONTACT PLATE METHOD PROCEDURE

MICROBIAL COUNT OF SURFACE CONTACT PLATE METHOD PROCEDURE

PREPARATION OF MEDIA:

·         Soyabean Casein Digest agar shall be prepared for bacterial and fungal count.

MICROBIAL COUNT OF SURFACE CONTACT PLATE METHOD PROCEDURE


PROCEDURE FOR PREPARATION OF PLATES: Microbial count of Surface contact plate method procedure

·         Sterile Surcon plates packed in plastic bags shall be taken to the laminar air flow station and removed from plastic bags              under laminar flow.

·         16 ml of sterilized media cooled to 450 C is poured aseptically using sterile measuring cylinder in separate surcon plates.

·         Medium shall have allowed to accommodate in the plate until its level is sufficiently higher than the edge of the plates, so that            the surface of media will have convex appearance.

·         Media is allowed to solidify. After solidification the lid is placed   back to its position.

·         Prepared plates are inverted and incubated at 300 C to 350 C for 48 hours to check contamination.

EXCEL SPREADSHEET VALIDATION FOR FDA 21 CFR PART 11

 

EXCEL SPREADSHEET VALIDATION FOR FDA 21 CFR PART 11

 

Preparation of Master Calculation Sheet: excel spreadsheet validation for fda 21 cfr part 11

EXCEL SPREADSHEET VALIDATION FOR FDA 21 CFR PART 11


·       Prepare the calculation sheet by using Microsoft Excel.

·       Format the cells by creating variables as is required for the calculation of individual tests.

·       Protect the cells using password, where no variables / readings need to be entered or where formula has been created for calculation of results.

·      Validate the input of cells where variables/readings need to be entered.

·       Prepare the calculation sheet for individual product/ calculation or may be for individual test if required.

·       Arrange the formula in resulting cell by selecting cells which contains formula data.

·        Protect the calculation bar, result bar etc. from the users after validating the calculation sheet.

Thursday, 7 October 2021

HVAC Validation Protocol PPT

 

HVAC Validation Protocol PPT

Protocol Approval

This is a specific protocol for Performance Qualification of HVAC System for Pharmaceutical Filling Area.

This protocol has been approved by the following:

        

HVAC Validation Protocol PPT

                                                       

Final Approval

Final approval has been given by the following:

Name    Signature             Date

Approved By

(Plant Head)      

               

Saturday, 2 October 2021

Master Formula Record Sample pdf

Master Formula Record Sample pdf 

In this post we have shared the Master Formula Record sample in PDF format ,
Please note that this is only sample formula record and we have taken the example of Deodorant spray , You can use this sample as per your requirement .
This PDF file can be best viewed on Web Version.

Friday, 1 October 2021

ALCOA Plus USFDA Guidelines

 

ALCOA Plus USFDA Guidelines

Data Quality Attributes – ALCOA | ALCOA Plus USFDA Guidelines

Attributable

•Each entry must be recorded, initialed and dated by the person performing the action

             Sign only for work you have performed or an activity that you have witnessed

             Electronic systems should retain all information as an audit trail

             Keep electronic passwords secret and secure

             Always Log Out or lock your computers when not in use!

Data Quality Attributes – ALCOA

Legible

             Electronic data should be easy to read and access

             Handwriting must be legible/readable in records, reports, etc.

             Record all data in permanent ink

             Changes made to data must not obscure/delete the original entry

             Use a single line to cross out and do not use correction fluid for paper records

             Electronic systems must retain all changes through audit trails

ALCOA Plus USFDA Guidelines

Sunday, 26 September 2021

Failure Investigation in Pharma

 

Failure Investigation in Pharma

Any batch failed to meet the acceptance criteria shall be evaluated as per Out of specification SOP

Failure Investigation in Pharma


·      When Out of Specification report received from Quality Control, Quality Assurance shall log in the Failure Investigation after confirmation of OOS result.

·       Executive/Designee-QA shall allocate the Investigation as below and record in log book as per Format given at the end of this SOP

·       For investigation, QA shall issue the Failure Investigation Report as per Format No.  given at the end of this SOP by assigning the Failure Investigation Report number. Failure Investigation Report shall be filled by concerned department for joint investigation.

·       After log in the Failure investigation report, QA shall immediately inform to Production Head regarding batch failure.

·       Investigation shall be carried out by technical team comprising of Production, Quality Control and Quality Assurance.

·       Investigation shall be initiated within 24 hours and completed within a week to find out reason for failure.

·       The batch record and supporting document shall be reviewed as per checklist and record observations as mentioned below

Terminal inspection in pharmaceutical industry

 

Terminal Inspection in Pharmaceutical Industry

·       Terminal inspection is the process for checking of defects in finished good prior to dispatch to market. The process is performed to check the effectiveness in finished good.

·      The IPQA person Check the product particulars to be inspected as offered by the packing in charge.

·       IPQA Personnel shall select randomly √n+1 of the total number of finished good. Whereas “n” is the total number of shipper of batch. Check the each & entire selected Corrugated box for following. Each Box shall be free from any defect.

Terminal inspection in pharmaceutical industry

Check the Corrugated box for the following. (But not limited to)

·         Product Name

·         Batch Number

·         Manufacturing Date

·         Expiry Date

·         Quantity in shipper

·         Condition of Corrugated Box

·         Shipper Weight

·         Shipper Label /Coding of Klass Marker

·         Shortage of packing

·         Colour of Klass Marker

·         Rusted pins

·         Condition of Tape

·         Shipper fill weight within limit (check against weight sheet)

Open the Corrugated Box and check for the following. (But not limited to)

·         Integrity and physical appearance of the pack.

·         Coding on Monocarton/Inner Corrugated Box (coding should be legible).

·         Batch Number, Manufacturing date, Expiry Date, MRP or Physician Sample.

·         Packing orientation and packing style.

·         Coding legibility

·         Condition of shrink sleeve (if applicable).

·         Condition of Can.

·         Leakage of Gas/Bulk

·         Color variation observed.

·         Heavily Dented Cans

·         Rust on Spray Cylinder

·         Very poor sleeving on Cans

·         Cracked Caps

·         Cap Orifice availability (if applicable)

·         Leakage observed.

·         Correctness of Quantity/Number of units and sub-units in the corrugated box (Finished Pack) and subsequent inner packing.

·         Any tear, breakage or damage of product or of any packing material which warrants and exhibits quality not conforming to the set standards etc.

·         The IPQA Shall Record the defects/Correctness observed on the above parameters in Terminal Inspection Report

·         if the defects warrants threat to the visual and intrinsic quality of the product then put the batch under hold and inform packing supervisor /in charge Production for the corrective actions.

·         If During inspection any minor defects observed, then one shipper from forward and backward should be check to minimise the error. The IPQA Shall inform the Concerned for correctness.

·         If any major defect is seen during inspection, ten shifts should be examined further and backward to reduce the error. IPQA will notify concerns for correctness

·         If any critical defect observed, then 100% batch shall be checked & the batch shall be dispatch after complete rectification through deviation

·         The defect can be categorised in Minor, Major, Critical as follow & suitable action shall be taken to minimize.

Possible Critical Defects (But not Limited) | Terminal Inspection in Pharmaceutical Industry

·         Wrong Coding /Without Coding

·         Can Printing defect

·         Without actuator and Cap

·         Leakage

The critical defects should be 0%.

Possible Major Defects (But not limited)

·         Illegible Coding

·         Colour Variation

·         Dust Cap Crack

The major defects should not be more than 2%.

Possible Minor Defects (But not limited)

·         Shipper damage

·         Mono Carton damage

·         Dirty cans

The minor Defects Should not be more than 3%.

Sunday, 29 August 2021

5 best Standard Operating Procedure Template

Standard Operating Procedure Template

Standard operating procedure is an important document to describe the procedure of any process properly so it is very important to design and elaborate the process through a well design template , so in this post you will get the most popular and widely used standard operating procedure template for creation of SOP.
I will add more template in this post in future .You can refer more SOP template from this Post 
5 best Standard Operating Procedure Template



Tuesday, 17 August 2021

Growth Promotion Test for Media as per USP


Growth Promotion Test for Media as per USP

Cultures for GPT

·         The growth promotion test is applicable to each batch/Lot of the dehydrated medium received and each lot of autoclaved media to check its suitability.

·         Perform the growth promotion test using one of these cultures for both agar & broth media.

             Staphylococcus aureus (NCIM 2079, ATCC 6538P)

             Escherichia coli (NCIM 2065, ATCC 8739)

             Salmonella abony (NCIM 2257, ATCC 6017)          

             Pseudomonas aeruginosa (NCIM2200, ATCC 9027) 

             Shigella Flexneri (NCIM 5265, ATCC 12022)

             Candida albicans (NCIM3471, ATCC 10231)

             Aspergillus brasiliensis (NCIM1196, ATCC16404)

             Bacillus subtilis (NCIM 2921, ATCC9372)

             Burkholderia cepacia (NCIM 5658, ATCC25416)

The details of media with respect to culture name and incubation temperature are as per format given at the end of this article

·         Prepare the medium as per sop.

·         Prepare the Microbial Culture Suspension as per the Procedure.

·         Prepare 100ml 0.9% w/v Normal saline in volumetric flask.

·         Ensure that solution is clear.

Saturday, 7 August 2021

cGMP vs GMP | The difference You need to Know

cGMP vs GMP | The difference You need to Know


To be precise there is not much of difference between GMP and cGMP, GMP (God manufacturing Practices) stresses on the use of QMS and Hygienic Practices while manufacturing of product and with an extra “C” (Current) cGMP stresses to use updated and current guidelines with GMP.

To understand where the regulations come from, who has enforcement authority, and why you need to comply

To understand the “Fundamentals”, “Benefits” and “Key Parts” of cGMPs

What are cGMPs?

Current Good Manufacturing Practices

Come from the Food Drug and Cosmetic Act

Rules set up by the FDA that drug manufacturers need to follow in order to ensure that a safe and effective product is manufactured

Why GMP?

Provides a high level assurance that medicines are manufactured in a way that ensures their safety, efficacy and quality

GMP applies to both Active Pharmaceutical Ingredients (APIs) and Finished Pharmaceutical Products (FPPs)

Fundamentals of cGMPs?

Quality Control, safety, and effectiveness must be designed and built into the product

Quality cannot be inspected or tested into a finished product

Each step of manufacturing must be controlled to maximize the chances that the Finished Good will be acceptable

What are the Benefits of cGMPs?

They outline a Quality System that reduces or prevents errors

Ensures products are safe for use in humans

Prevent/control contamination and cross-contamination

Minimizes variations in potency of the drug

Ensures reproducible physiological activity

Prevent side effects and toxicity due to variations in drug content and potency

Prevents mislabelling and adulteration

Good Manufacturing Practices

Quality assurance

Sanitation and hygiene

Qualification and validation

Product recalls

Contract production and analysis

General

                The contract giver

                The contract accepter

                The contract

Self-inspection and quality audits

                Items for self-inspection

                Self-inspection team

                Frequency of self-inspection

                Self-inspection report

                Follow-up action

                Quality audit

                Suppliers’ audits and approval

Training

Building and Facilities

                General

                Ancillary areas

                Storage areas

                Weighing areas

                Production areas

                Quality control area

Materials

                Starting materials

                Packaging materials

                Intermediate and bulk products

                Finished products

                Rejected, recovered, reprocessed and reworked materials

                Recalled products

                Returned goods

                Reagents and culture media

                Reference standards

                Waste materials

                Miscellaneous Equipment

Documentation or Records

Documents required:

Labels

Testing procedures

Specifications for starting and packaging materials, for intermediate and bulk products and for finished products

Master formulae and Batch Processing Records

Packaging instructions and Batch Packaging Records

Standard Operating procedures (SOP's) and records

Logbook